Guaifenesin

Guaifenesin
SPL v5
SPL
SPL Set ID 40291505-55ca-0759-e063-6394a90acee1
Route
ORAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Stearic Acid Magnesium Stearate Sodium Starch Glycolate Type A Povidone K30 Microcrystalline Cellulose Maltodextrin Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: EB Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-13

Description

cough, cold


Medication Information

Warnings and Precautions

Indications and Usage

cough, cold

Dosage and Administration

Description

cough, cold

Section 51727-6

Calcium sennosides 20% IH, Colloidal Silicon Di oxide USP/NF, Croscarmellose sodium USP/NF, Crospovidone [Kollidon] USP/NF, Dicalcium phosphate/ dibasic calcium phosphate [DIREC] USP/NF, Filmcoat AMB-51D0393632-Blue lake IH, Magnesium stearate. USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Sodium lauryl sulfate USP/NF, Stearic acid powder USP/NF, Purified water

Section 51945-4

Sennosides Tablets USP, 25 mg Label

Section 55105-1


Structured Label Content

Indications and Usage (34067-9)

cough, cold

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 51727-6 (51727-6)

Calcium sennosides 20% IH, Colloidal Silicon Di oxide USP/NF, Croscarmellose sodium USP/NF, Crospovidone [Kollidon] USP/NF, Dicalcium phosphate/ dibasic calcium phosphate [DIREC] USP/NF, Filmcoat AMB-51D0393632-Blue lake IH, Magnesium stearate. USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Sodium lauryl sulfate USP/NF, Stearic acid powder USP/NF, Purified water

Section 51945-4 (51945-4)

Sennosides Tablets USP, 25 mg Label

Section 55105-1 (55105-1)


Advanced Ingredient Data


Raw Label Data

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