Label: DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide,phenylephrine hydrochloride doxylaminesucinate kit
- NDC Code(s): 82501-4672-4
- Packager: Gobrands, Inc. (Goodnow)
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 15, 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
-
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
NIGHTTIME
-
temporarily relieves these common cold/flu symptoms`
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing
- fever
- cough due to minor throat and bronchial irritation
- temporarily relieves common cold and flu symptoms
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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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 exceed recommended dosage.
NIGHTTIME
- 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
- pain 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
Taking more than the recommended dose (overdose) may cause 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.
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Directions
DAYTIME
- do not take more than 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
NIGHTTIME- do not take more than directed (see Overdose warning)
- Do not take more than 4 doses in any 24-hours period
- 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 6 hours
- children under 12 years of age: do not use
- 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
acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium trisodium citrate dihydrate
- Questions or comments?
-
Principal Display Panel
Compare to active ingredients in Vicks® DayQuil® & NyQuil® Cold & Flu†
DAYTIME
NON-DROWSY
Cold + Flu
Day Relief
Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl
Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant
Alcohol-free / Antihistamine-free
Multi-Symptom Relief
Headaches & Fever
Sore Throat
Minor Aches & Pains
Nasal Congestion
Cough
NIGHTTIME
CHERRY FLAVOR
Cold + Flu
Night Relief
Acetaminophen
Dextromethorphan HBr
Doxylamine Succinate
Pain Reliever
FeverReducer
Cough Suppressant
Antihistamine
Alcohol 10%
Multi-Symptom Relief
Headache & Fever
Sore Throat
Minor Aches & Pains
Sneezing
Running Nose
Cough
FL OZ (mL)
When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.
†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.
DISTRIBUTED BY: GOBRANDS, INC.
PHILADELPHIA,PA 19123
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide,phenylephrine hydrochloride doxylaminesucinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82501-4672 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82501-4672-4 1 in 1 KIT; Type 0: Not a Combination Product 04/29/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 355 mL Part 2 1 BOTTLE 355 mL Part 1 of 2 COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Item Code (Source) NDC:82501-4661 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 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 1 355 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 04/29/2022 Part 2 of 2 NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Item Code (Source) NDC:82501-3431 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 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 355 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 04/29/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/29/2022 Labeler - Gobrands, Inc. (Goodnow) (057499049)
