CHILDRENS MUCUS COUGH AND CONGESTION RELIEF- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Childrens Mucus Cough and Congestion Relief by

Drug Labeling and Warnings

Childrens Mucus Cough and Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • stuffy nose
  • nasal congestion due to a cold
  • the intensity of coughing
  • the impulse to cough to help the child get to sleep

Warnings

Do not use

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

• diabetes
• heart disease
• thyroid disease
• high blood pressure
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• do not take more than 6 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• dose as follows or as directed by a doctor

• Age: Dose
• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: 5 mL every 4 hours
• children under 4 years: do not use

Other information

• each 5 mL contains: sodium 3 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC: 0363-1056-88

Walgreens
WALGREENS PHARMACIST RECOMMENDED†

Compare to the active ingredients in
Children’s Mucinex® Cough & Congestion††

Children’s
Mucus
Cough &
Congestion
Relief

DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl /
NASAL DECONGESTANT
ORAL SOLUTION

Relieves
chest congestion,
cough & stuffy nose
Breaks up
mucus

AGES
4-11
YEARS

Berry
flavor

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered
trademark Children’s Mucinex® Cough & Congestion.

50844      ORG02230568

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.

Walgreens 44-056

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS COUGH AND CONGESTION RELIEF 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1056
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
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	red	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1056-88	1 in 1 CARTON	05/12/2023
1		201 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 Drug	M012	05/12/2023

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(0363-1056) , pack(0363-1056)