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

exchange select™

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
(click image for full-size original)

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

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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