Label: COUGH COLD AND SORE THROAT CHILDRENS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 0363-4050-04
- Packager: Walgreens
- 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 March 3, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
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Uses
- temporarily relieves these common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion
- stuffy nose
- sore throat
- minor aches and pains
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold and flu symptoms:
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Warnings
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
- with any other drug containing acetaminophen (prescription or monprescription). 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if your child has
- liver disease
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with a rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- 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
- keep dosing cup with product
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- 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
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Cold, Cough & Sore Throat††
Children's
Cold, Cough & Sore Throat
ACETAMINOPHEN 325 mg /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg /
COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
- Relief from cough, sore throat, stuffy nose & chest congestion
- Breaks up mucus
AGES 6 - 11 YEARS
FL OZ (mL)
Berry flavor
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Package Label
-
INGREDIENTS AND APPEARANCE
COUGH COLD AND SORE THROAT CHILDRENS
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4050 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) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 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 NDC:0363-4050-04 1 in 1 BOX 10/31/2014 1 118 mL in 1 BOTTLE, PLASTIC; 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 10/31/2014 Labeler - Walgreens (008965063)
