NDC | 53808-0822-1 |
Set ID | 02f8cd87-ba7c-4314-9475-8a5b72c60545 |
Category | HUMAN OTC DRUG LABEL |
Packager | State of Florida DOH Central Pharmacy |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purposes
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
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Keep out of reach of children.
Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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DOSAGE & ADMINISTRATION
Directions
adults and children 12 years of age and over take 2 capsules every 4 hour to 6 hours, not to exceed 8 capsules in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years of age Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause liver damage. DO NOT EXCEED RECOMMENDED DOSE
Other information
- store at room temperature, USP
- use by expiration date on pckage
- do not use if capsule band or imprinted safety seal under cap is broken or missing
- side effects occur
- You may report side effects at 1-800-616-2471 (Toll Free)
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Inactive Ingredients
FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.
*Major Extra Strength Mapap is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
Distributed by:
MAJOR PHARMACEUTICALS
Livonia, MI 48150 USAThis Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United StatesThey are supplied by State of Florida DOH Central Pharmacy as follows:
NDC Strength Quantity/Form Color Source Prod. Code 53808-0822-1 500 mg 30 Capsules in a Blister Pack RED 0904-1987 - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAPAP EXTRA STRENGTH
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0822(NDC:0904-1987) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape CAPSULE Size 22mm Flavor Imprint Code CPC;617 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0822-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 01/01/2013 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0822)