FDA Label for Walgreens

View Indications, Usage & Precautions

DRUG FACTS
PURPOSES
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 ML BOTTLE)

Walgreens Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts

Active ingredients (in each 5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 2.5 mg

Purposes

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:
- •nasal congestion due to a cold
- •stuffy nose

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. Avoid foods or beverages that contain caffeine.

Ask A Doctor Before Use If The Child Has

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

When Using This Product

•Do not use more than directed

Stop Use And Ask A Doctor If

•your child gets nervous, dizzy or sleepless
•symptoms do not get better within 7 days or occur with fever
•cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

Keep Out Of Reach Of Children.

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

Directions

•do not give more than 6 doses in any 24 hour period
•measure only with dosing cup provided
•do not use dosing cup with other products
•mL= milliliter

Age	Dose
Children 6 years to under 12 years	10 mL every 4 hours
Children 4 years 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
•very low sodium
•store at room temperature
•do not refrigerate
•dosing cup provided

Inactive Ingredients

anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

Package Label-Principal Display Panel 4 Fl Oz (118 Ml Bottle)

Walgreens

Compare to Children’s Mucinex® Stuffy Nose & Cold active ingredients††

NDC 0363-7480-04

Children's Dye-Free Stuffy Nose & Cold

GUAIFENESIN, USP 100 mg/EXPECTORANT
PHENYLEPHRINE HCl, USP 2.5 mg/

NASAL DECONGESTANT

DYE FREE

ALCOHOL FREE

•Relief from stuffy nose & chest congestion
•Breaks up mucus

4 YEARS & OLDER

Mixed Berry Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

4 FL OZ (118 mL)

DOSAGE CUP PROVIDED

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015