COUGH COLD AND SORE THROAT CHILDRENS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Walgreens

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.

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Drug Facts

Active ingredients (in each 10 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product,

do not use more than directed (see Overdose warning).

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.

Directions

Other information

Inactive ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

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

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

WALGREENS Children's Cold, Cough, and Sore Throat Berry Flavor

COUGH COLD AND SORE THROAT  CHILDRENS
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-4050-041 in 1 BOX10/31/2014
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/2014
Labeler - Walgreens (008965063)

Revised: 3/2022
Document Id: c1b95f3b-e9e7-4c17-a09d-dedff0b80bfe
Set id: 400a0998-e276-4c8d-9b41-145b1b405fff
Version: 7
Effective Time: 20220303
 
Walgreens