Active ingredient (in each tablet)

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

Directions:

adults and children 12 years of age and over: 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: do not use

Other information

each tablet contains: sodium 1.24 mg VERY LOW SODIUM
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
read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

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

Questions or Comments

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

Principal Display Panel

200 ct

200 ct 300 ct

300 ct 500 ct

500 ct

MUCUS RELIEF
guaifenesin 400 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71309-008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	G400
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71309-008-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC:71309-008-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2016
3	NDC:71309-008-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/13/2016

Labeler - Safrel Pharmaceuticals, LLC (080566287)

Mucus Relief Guaifenesin 400 mg Caplets