GUAIFENESIN 200MG- guaifenesin tablet

Guaifenesin 200mg by

Drug Labeling and Warnings

Guaifenesin 200mg by is a Otc medication manufactured, distributed, or labeled by HEALTHLIFE OF USA LLC, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

• Temporary symptomatic relief from congested chests and cough.

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 a doctor before use if you have

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

When using this product

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

Stop use and ask a doctor ifcough lasts for more than 7 days please consult your physicain or healthcare provider.

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 (1-800-222-1222) right away.

Directions

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

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 Ingredients

Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrrolidone (PVPK30), Colloidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 200MG 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-148-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	08/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/22/2025

Labeler - HEALTHLIFE OF USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	manufacture(69517-148)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(69517-148)