- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
children under 6 years of age: consult a doctor - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXCAUGH
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51467-009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color yellow Score no score Shape ROUND Size 10mm Flavor Imprint Code FORTUNE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51467-009-01 2 in 1 BOX 04/26/2016 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51467-009-02 3 in 1 BOX 03/21/2018 2 12 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 final part341 04/26/2016 Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561) Establishment Name Address ID/FEI Business Operations FORTUNE PHARMACAL COMPANY, LIMITED 686280561 manufacture(51467-009)