GILTUSS EX MAXIMUM STRENGTH EXPECTORANT tablet

Giltuss EX Maximum Strength Expectorant by

Drug Labeling and Warnings

Giltuss EX Maximum Strength Expectorant by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, Neeyaan, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient Purpose (in each extended-release bi-layer tablet)

Guaifenesin, 1200 mg....................................................................Expectorant

PURPOSE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.

Warnings

• Do not use for children under 12 years

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness.

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

Directions

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for the timing of meals
• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours
• Do not exceed 2 tablets in 24 hours
• Do not use for children under 12 years of age

Other information

• Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing
• Store between 20°-25°C (68°-77°F)
• Tamper evident: Do not use if carton is open or if printed seal under cap is broken or missing.

INACTIVE INGREDIENT

Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch  glycolate.

Questions or comments?

Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.

revised: 08/25

PRINCIPAL DISPLAY PANEL

GILTUSS EX MAXIMUM STRENGTH EXPECTORANT / EXPECTORANTE (Guaifenesin, 1200 mg) - NDC 58552-341-14 - 14 Tabs Bottle label

INGREDIENTS AND APPEARANCE

GILTUSS EX MAXIMUM STRENGTH EXPECTORANT 
giltuss ex maximum strength expectorant tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-341
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-341-14	1 in 1 CARTON	10/07/2025
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58552-341-07	1 in 1 CARTON	10/07/2025
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/07/2025

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Ganules India Limited		918609236	manufacture(58552-341) , analysis(58552-341) , pack(58552-341) , label(58552-341)