OTC Medication Information: Mucus Relief

MUCUS RELIEF- guaifenesin tablet, film coated
ARMY AND AIR FORCE EXCHANGE SERVICE

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 ingredient (in each immediate-release tablet)

Guaifenesin 400 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 you have

• cough accompanied by too much phlegm (mucus)
  
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take with a full glass of water
  
• adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
• children under 12 years: do not use

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

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Mucus Relief
Guaifenesin 400 mg
Expectorant

Relieves Chest Congestion
Thins & Loosens Mucus

4 Hours of Relief

Immediate
Release

Film Coated
60 Tablets

Actual Size

✓ quality
value

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 117881-800-426-9391

50844 ORG011853211

Exchange Select 44-532

MUCUS RELIEF guaifenesin tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-932 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID

Product Characteristics Color blue Score 2 pieces Shape ROUND Size 13mm Flavor Imprint Code 44;532 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55301-932-91 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55301-932-91)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/22/2005

Labeler — ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (55301-932)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (55301-932), pack (55301-932)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	manufacture (55301-932)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (55301-932)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		117025878	manufacture (55301-932)

Revised: 06/2022 ARMY AND AIR FORCE EXCHANGE SERVICE