Children's Chest Congestion Relief

Childrens Chest Congestion Relief by

Drug Labeling and Warnings

Childrens Chest Congestion Relief by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, Aptapharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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Children's Chest Congestion Relief

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 Poison
Control Center right away.

Directions

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

• Children 6 yearsto 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 BY: 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

Bottle Label

res

CHILDRENS CHEST CONGESTION RELIEF 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-375
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-375-04	1 in 1 CARTON	09/18/2021
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/18/2021	12/01/2022

Labeler - WinCo Foods, LLC (056098817)

Registrant - Aptapharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
Aptapharma Inc.		790523323	manufacture(67091-375)

Revised: 12/2022

Document Id: bb388919-dc5f-4fe1-a37d-e8467b45e7ab

34390-5

Set id: 44d0b0bb-7473-4373-8a90-cec803c0bbd6

Version: 2

Effective Time: 20221216