OTC Medication Information: Childrens Chest Congestion Relief

CHILDRENS CHEST CONGESTION RELIEF- guaifenesin solution
WinCo Foods, LLC

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 FACTS

Active ingredient
(in each 5mL teaspoonful)
Guaifenesin, USP 100 mg

Purpose
Expectorant

Uses ■ Helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial
passageways of bothersome mucus and make
coughs more productive

Warnings

Ask a doctor before use if the child has:
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough 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 persistent headache. These could be signs
of a serious illniess.

Keep out of reach of children In case of
overdose, get medical help or contact a PoisonControl Center right away.

Directions

■ do not take more than 6 doses in any 24-hour period

age dose

Children 6 yearst o under 12 years

1-2 teaspoonfuls every 4 hours.

Children 4 years to under 6 years

1/2-1 teaspoonful every 4 hours

Children under4 years

do not use

Other information
each 5 mL contains: sodium 3 mg
■ store between 20-25ºC (68-77ºF)
■ do not refrigerate
■ dosing cup provided
Keep carton for full directions for use

Inactive ingredients
Anhydrous citric acid, dextrose, FD&C Blue # 1,
FD&C Red # 40, flavor, glycerin, maltltol, propylene
glycol, purified water, saccharin sodium, sodium
benzoate, sucralose, xanthan gum

Questions? Call 1-800-824-1706
Monday — Friday 9am — 4pm MST

Package Labeling

WinCo®

FOODS

Chest
Congestion
Relief

Children’s

** Compare to the active ingredient in
Children’s MUCINEX® Chest Congestion

GUAIFENESIN ORAL SOLUTION
100 mg per 5 mL/
EXPECTORANT

Alcohol Free

Thins & Loosens Mucus

For Ages 4-12 Years

Grape Flavor

4 FL OZ (118 mL)

DISTRIBUTED B Y: WINCO FOODS,LLC, BOISE, ID 83704

** This product is not manufactured or distributed by
RECKITT BENCKISER INC., distributor of
Children’s MUClNEX​® Chest Congestion.

Comments & Questions?
800-824-1706 · www.wincofoods.com

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Carton Label

Crtn 375
(click image for full-size original)

Bottle Label

Botl 375
(click image for full-size original)

res

CHILDRENS CHEST CONGESTION RELIEF guaifenesin solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
DEXTROSE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
MALTITOL
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color purple Score
Shape Size
Flavor grape Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-375-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (67091-375-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/18/2021
Labeler — WinCo Foods, LLC (056098817)
Registrant — Aptapharma Inc. (790523323)
Establishment
Name Address ID/FEI Operations
Aptapharma Inc. 790523323 manufacture (67091-375)

Revised: 09/2021 WinCo Foods, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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