NDC | 47682-210-13, 47682-210-33, 47682-210-64, 47682-210-83, 47682-210-99 |
Set ID | 0667ec26-c2cd-153c-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Unifirst First Aid Corporation |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART335 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are:
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor or pharmacist if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
-
DOSAGE & ADMINISTRATION
Directions
- chew or dissolve in mouth
- do not swallow tablets whole
- drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
Adults and children: (12 years and over)
- chew 2 tablets every 1/2 to 1 hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
Children under 12 years:
ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Medique Diotame Label
-
INGREDIENTS AND APPEARANCE
MEDIQUE DIOTAME
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) ACACIA (UNII: 5C5403N26O) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor PEPPERMINT Imprint Code RH;046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-210-83 15 in 1 BOX 04/01/2014 1 NDC:47682-210-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-210-33 50 in 1 BOX 04/01/2014 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-210-13 250 in 1 BOX 04/01/2014 3 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-210-64 12 in 1 BOX 04/01/2014 4 2 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:47682-210-99 2 in 1 PACKET; Type 0: Not a Combination Product 04/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 04/01/2014 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 relabel(47682-210) , repack(47682-210)