Mucus Relief Cough Childrens: Package Insert and Label Information

MUCUS RELIEF COUGH CHILDRENS- dextromethorphan hydrobromide and guaifenesin 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.

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purposes

Cough suppressant

Expectorant

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
    • the intensity of coughing
    • the impulse to cough to help your 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 taking this product.

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor if

cough lasts more than 7 days, 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
age dose
children 6 to 12 years 5-10 mL every 4 hours
children 4 to 5 years 2.5-5 mL every 4 hours
children under 4 years do not use

Other information

  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Questions or comments?

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

Principal Display Panel

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

Children’s

Cough

DEXTROMETHORPHAN HBr 5 mg /

COUGH SUPPRESSANT

GUAIFENESIN 100 mg / EXPECTORANT

Alcohol Free

  • Breaks up the mucus that causes congestion while controlling coughs

AGES 4-11 YEARS

DOSAGE CUP PROVIDED

Cherry flavor

FL OZ (mL)

††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Mucinex®.

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

Package Label

Dextromethorphan HBr 5 mg, Guaifenesin 100 mg
(click image for full-size original)

WALGREENS Children’s Cough Cherry Flavor

MUCUS RELIEF COUGH CHILDRENS
dextromethorphan hbr, guaifensin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5527
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
DEXTROSE
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
POTASSIUM SORBATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SODIUM HYDROXIDE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-5527-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-5527-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/25/2022
Labeler — Walgreens (008965063)

Revised: 03/2022 Walgreens

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