Mucus reliefimmediate release tablet

Active ingredient

Guaifenesin 400 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Warnings

Ask a doctor before use if you have

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

When using this product

do not exceed recommended dosage
do not use for more than 7 days

Stop use and ask a doctor if

cough lasts for more than 7 days, recurs, or is accompanied by 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Other information

store at 25 C (77 F) excursions between 15-30 C (59-86 F) keep in a dry place and do not expose to heat do not use if imprinted safety seal under cap is broken or missing You may report side effects to 1-888-952-0050

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Ingredients and appearance - Product information

Mucus reliefimmediate release tablet- Guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68016-175
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 1

Inactive Ingredients

Ingredient Name Code
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium starch glycolate type a corn ( UNII: AG9B65PV6B)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color white Size 17 mm
Shape ROUND Score 2
Imprint Code TCL272

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68016-175-50 50 in 1 CARTON 2014/12/29

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA 2014/12/29

Labeler - Chain Drug Consortium( 101668460)

Establishment

Name ID/FEI Business Operations
Chain Drug Consortium 101668460 label( 68016-175), manufacture( 68016-175), pack( 68016-175), relabel( 68016-175), repack( 68016-175)

Package/label principal display panel