Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet
- NDC Code(s): 11822-6304-1, 11822-6304-2, 11822-6304-3
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks ever day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek a medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient of Tylenol® 8 HR Arthritis Pain
SEE NEW WARNING
8 HR ARTHRITIS PAIN RELIEF
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS USP 650 mg
PAIN RELIEVER/FEVER REDUCER
For the temporary relief of minor arthritis pain
Contain no aspirin
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
CAPLETS
*CAPSULE-SHAPED BI-LAYER TABLETS
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain.
TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING.
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
- Product Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6304 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code G650 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-6304-1 1 in 1 BOX 05/29/2020 05/29/2025 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11822-6304-3 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/29/2020 05/29/2025 3 NDC:11822-6304-2 1 in 1 BOX 05/29/2020 05/29/2025 3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211544 05/29/2020 05/29/2025 Labeler - Rite Aid Corporation (014578892)