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

age                                                     dose                                                

Children 6 years
to under 12 years

1-2 teaspoonfuls
every 4 hours.

Children 4 years
to under 6 years

1/2-1 teaspoonful
every 4 hours 

Children under
4 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

Crtn 375

Bottle Label

Botl 375

res

CHILDRENS CHEST CONGESTION RELIEF 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67091-375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScore    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67091-375-041 in 1 CARTON09/18/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/18/202112/01/2022
Labeler - WinCo Foods, LLC (056098817)
Registrant - Aptapharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
Aptapharma Inc.790523323manufacture(67091-375)

Revised: 12/2022
 

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