Label: DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 49035-938-04
- Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 26, 2024
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- ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL)
- ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 10 mL)
- PURPOSE FOR DAYTIME
- PURPOSE FOR NIGHTTIME
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USE(S)
DAYTIME
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
NIGHTTIME
- temporarily relieves these common cold and flu symptoms:
- cough
- sore throat
- nasal congestion
- runny nose
- minor aches and pains
- headache
- sinus congestion and pressure
- sneezing
- temporarily reduces fever
- controls cough to help your child get to sleep
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WARNINGS
NIGHTTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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
in a child who is 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.
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.
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on the skin
- in a child who is 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
-
ASK A DOCTOR BEFORE USE IF CHILD HAS
DAYTIME
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
NIGHTTIME
- liver disease
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- glaucoma
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD
- WHEN USING THIS PRODUCT
-
STOP USE AND ASK DOCTOR IF
DAYTIME
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious illness.
NIGHTTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
-
KEEP OUT OF REACH OF CHILDREN
DAYTIME
In case of overdose, get medical help or contact a Poison Control Center right away.
NIGHTTIME
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms. -
DIRECTIONS
DAYTIME
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use - mL = milliliter
NIGHTTIME
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- shake well before use
- do not give more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- children 6 to under 12 years of age: 10 mL in dosing cup provided.
- children under 6 years of age: do not use.
- OTHER INFORMATION
-
INACTIVE INGREDIENTS
DAYTIME
citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.
NIGHTTIME
citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum. - QUESTIONS OR COMMENTS?
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PRINCIPAL DISPLAY PANEL
DAY & NIGHT VALUE PACK
NDC 49035-938-04
equateTM
Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*
Daytime
Ages 4-12 years
Children's Multi-Symptom Cold
Dextromethorphan HBr 5mg - Cough SuppressantGuaifenesin100mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant
- Relieves Stuffy Nose
- Soothes Cough
- Relieves Chest Congestion
- Thins & loosens Mucus
Very Berry Flavored
Dosage cup included
NIGHTTIME
Ages 6-12 yearsChildren's Multi-Symptom ColdAcetaminophen 325mg - Pain reliever/fever reducerDiphenhydramine HCl 12.5mg - Antihistamine/cough suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant- Temporarily reduces fever
- Soothes cough & sore throat
- Relieves nasal congestion & sneezing
Mixed berry flavored Dosage Cup Included
TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL
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INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME CHILDRENS MULTI-SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-938 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-938-04 1 in 1 KIT; Type 0: Not a Combination Product 11/26/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 CHILDRENS MULTI-SYMPTOM COLD DAYTIME
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Item Code (Source) NDC:79903-270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor BERRY (Verry Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 118 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 11/26/2024 Part 2 of 2 EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquidProduct Information Item Code (Source) NDC:49035-623 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor BERRY (Mixed Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 118 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 11/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/26/2024 Labeler - Wal-Mart Stores, Inc. (051957769) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(49035-938)