Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet
- NDC Code(s): 69842-093-01, 69842-093-10, 69842-093-15, 69842-093-24
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 21, 2022
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- 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
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Directions
- do not take more than directed (see Overdose warning)
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adults and children 12 years and over
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
†Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain
Extended-release
Pain Reliever
Acetaminophen 650 mg
Pain reliever/Fever reducer
For up to 8 hours relief of minor muscle aches & pain
Caplets*
(*capsule-shaped bi-layer tablets)
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy Inc
one CVS Drive, Woonsocket RI 02895
- Product Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-093 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 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 LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 511 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-093-10 1 in 1 BOX 04/01/2020 04/30/2025 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69842-093-24 1 in 1 BOX 04/01/2020 04/30/2025 2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:69842-093-15 1 in 1 BOX 04/01/2020 04/30/2025 3 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:69842-093-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2020 04/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207035 04/01/2020 04/30/2025 Labeler - CVS Pharmacy (062312574)