Label: DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF- acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci doxylaminesucinate kit
- NDC Code(s): 49580-0813-6
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- Active ingredients (in each 15 mL) DAYTIME
- Active ingredients for (in each 30 mL) NIGHTTIME
- Purposes for Day Time
- Purpose for Night Time
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Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- cough due to minor throat and bronchial irritation
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
NIGHTTIME
-
temporarily relieves these common cold/flu symptoms
- nasal congestion
- sore throat
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces
- fever
- cough to help you sleep
- swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves common cold and flu symptoms
-
Warnings
DAYTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash.
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash.
if a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
DAYTIME NIGHTTIME
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if you have
DAYTIME
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
NIGHTTIME
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- glaucoma
- a sodium-restricted diet
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
DAYTIME
taking the blood thinning drug warfarin.
NIGHTTIME
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
DAYTIME
do not take more than directed
NIGHTTIME
- do not take more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
NIGHTTIME
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash, or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
DAYTIME NIGHTTIME
Overdose warning:Taking more than the recommended dose (overdose) may couse liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
DAYTIME
- take only as directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use -
when using other Daytime or Night time products, carefully read each label to ensure correct dosing
NIGHTTIME
- take only as directed (see Overdose warning)
- Do not exceed 4 doses per 24
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
- Other information
-
Inactive ingredients
Day Time
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum
Night Time
anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dehydrate, sorbitol, sucralose, xanthan gum
- Questions or comments?
-
Principal Display Panel
when using daytime and nighttime products, carefully read the labeling to ensure correct dosing.
Compare to the active ingredients in VICKS® DAYQUIL® and NYQUIL® Severe Cold & Flu*
DAYTIME
Severe
day time cold & flu relief
Acetaminophen 325 mg Pain Reliever / Fever Reducer
Dextromethorphan HBr 10 mg Cough Suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCI 5 mg Nasal Decongestant
relieves:
- headache, fever, sore throat, minor aches & pains
- nasal/sinus congestion & sinus pressure
- Cough
- Chest congestion
For ages 6 years and over
max strength
non-drowsy
alcohol free
NIGHTTIME
maximum strength
severe
night time cold & flu relief
Acetaminophen 650 mg Pain Reliever / Fever Reducer
Dextromethorphan HBr 20 mg Cough Suppressant
Doxylamine Succinate 12.5 mg Antihistamine
Phenylephrine HCI 10 mg Nasal Decongestant
relieves:
- ache, fever, sore throat,
- cough
- Runny nose & sneezing
- nasal & sinus congestion
alcohol free
FL OZ (mL)
berry Flavor
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci doxylaminesucinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0813 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0813-6 1 in 1 KIT; Type 0: Not a Combination Product 03/26/2021 03/28/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 237 mL Part 2 1 BOTTLE 237 mL Part 1 of 2 SEVERE COLD AND FLU RELIEF DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Item Code (Source) NDC:49580-0415 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/26/2021 03/28/2025 Part 2 of 2 SEVERE COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquidProduct Information Item Code (Source) NDC:49580-4160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/26/2021 02/28/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/26/2021 03/28/2025 Labeler - P & L Development, LLC (101896231)
