Label: CRAMP TABS- acetaminophen, pamabrom tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67060-700-68 - Packager: ADVANCED FIRST AID, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 10, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if:
•you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription
or non-prescription)
• you have 3 or more alcoholic drinks every day while using this product
Precaution: If a rare sensitivity reaction occurs, the drug should be discontinued.
Do not use:
• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
• for more than 10 days for pain unless directed by a doctor
- than 3 days unless directed by a doctor
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when using this product do not exceed recommended dose
Stop use and ask a doctor if:
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symptoms do not improve
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new symptoms occur
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pain gets worse or lasts for more than 10 days
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redness or swelling is present
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CRAMP TABS
acetaminophen, pamabrom tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-700 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 pamabrom (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) pamabrom 25 Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) sodium starch glycolate type a corn (UNII: AG9B65PV6B) Product Characteristics Color white (SNOW WHITE) Score no score Shape CAPSULE Size 11mm Flavor Imprint Code FEM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-700-68 100 in 1 CARTON 08/10/2015 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/10/2015 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-700) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-700)
