Label: AHIST- chlorcyclizine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 58407-025-01, 58407-025-06, 58407-025-30 - Packager: Magna Pharmaceutcals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 17, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each immediate-release tablet)
- Purpose
- Uses
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Warnings
Do not exceed recommended dosage.
Do not take this product unless directed by a doctor if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor Children under 6 years of age Consult a doctor - Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 Tablet Carton
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INGREDIENTS AND APPEARANCE
AHIST
chlorcyclizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58407-025 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P) CHLORCYCLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color green Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code AHIST;025 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58407-025-30 30 in 1 BOX 01/15/2013 1 NDC:58407-025-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:58407-025-06 6 in 1 BOX 01/31/2013 09/01/2019 2 NDC:58407-025-01 1 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 01/15/2013 Labeler - Magna Pharmaceutcals, Inc. (620988360)
