Label: CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 49035-772-03
- Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 8, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS (in each 10 mL)
- PURPOSE
-
USE(S)
temporarily relieves these common cold and flu symptoms:
- nasal congestion
- stuffy nose
- cough due to minor throat and bronchial irritation
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
-
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hous, 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
-
STOP USE AND ASK DOCTOR IF
- 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 rash or headache that lasts. These could be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- 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
- Children 6 to under 12 years of age: 10 mL in dosing cup provided.
- mL = milliliter
- Children under 6 years of age: do not use.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
-
PRINCIPAL DISPLAY PANEL
NDC 49035-772-03
equate
Compare to Children's Mucinex®Multi-Symptom Cold & Fever active ingredients*
Children's Multi-Symptom Cold & Fever Liquid
Acetaminophen 325 mg
Pain reliever/Fever ReducerDextromethorphan HBr 10 mg
Cough Suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCl 5 mgNasal Decongestant
AGES 6 to 12 YEARS
- Relieves nasal and chest congestion
- Soothes Cough
- Reduces fever
- Thins and loosens Mucus
- Alcohol Free
- Berry Burst Flavored
4 FL OZ (118 mL)
-
INGREDIENTS AND APPEARANCE
CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-772 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-772-03 1 in 1 CARTON 08/01/2017 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 FINAL part341 08/01/2017 Labeler - Wal-Mart Stores, Inc. (051957769)