Giltuss Ex Maximum Strength

Giltuss Ex Maximum Strength
SPL v1
SPL
SPL Set ID 950db1ca-6936-47f8-a112-e3594d4c922c
Route
ORAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: G Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-07
Description

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

Purpose

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

Medication Information

Purpose

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

Description

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

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.
Section 50565-1

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).

Section 51727-6

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

Section 53414-9

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

Section 55105-1

Warnings
  • Do not use for children under 12 years
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
Drug Facts

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.
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

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.

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)
Active Ingredient Purpose (in Each Extended Release Bi Layer Tablet)

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

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.
Section 50565-1 (50565-1)

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).

Section 51727-6 (51727-6)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Warnings
  • Do not use for children under 12 years
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
Drug Facts

Other Information (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.
Questions Or Comments? (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 (PRINCIPAL DISPLAY PANEL)

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

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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)
Active Ingredient Purpose (in Each Extended Release Bi Layer Tablet) (Active ingredient Purpose (in each extended-release bi-layer tablet))

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:40.510875 · Updated: 2026-03-14T23:13:00.870746