Guaifenesin by Health Pharma USA LLC / Elysium Pharmaceuticals Ltd. / HHH Pharmaceuticals GUAIFENESIN tablet

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC, Elysium Pharmaceuticals Ltd., HHH Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each caplet)

Guaifenesin 400 mg

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Uses

• Temporary symptomatic relief from congested chests and cough.

WARNINGS

​Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

ASK DOCTOR

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

When using this product

• Do not exceed recommended dosage.
• Do not consume alcohol, benzodiazepines or opioids.

STOP USE

Stop use and ask a doctor if

cough lasts for more than 7 days please consult your physician or healthcare provider.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or  contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years of age and over:take 1 caplet a day.
• Children under 12 years:Do not use.
• Do not exceed 4 doses in 24 hours.

OTHER SAFETY INFORMATION

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.
■ Read all product information before use.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

INACTIVE INGREDIENT

Inactive ingredients
Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.

QUESTIONS

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71679-309
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	G400
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71679-309-00	38500 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2024
2	NDC: 71679-309-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/07/2024

Labeler - Health Pharma USA LLC (080804485)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd.		915664486	manufacture(71679-309) , analysis(71679-309)

Establishment
Name	Address	ID/FEI	Business Operations
HHH Pharmaceuticals		144848997	pack(71679-309)