Label: 8 HOUR PAIN RELIEF- acetaminophen tablet, film coated, extended release
- NDC Code(s): 42507-217-71, 42507-217-78
- Packager: HyVee Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
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- Active ingredient (in each caplet)
Acetaminophen 650 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
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 every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek 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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
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
- do not use
- Other information
- store at 20-25 °C (68-77 °F). Avoid excessive heat 40 °C (104 °F).
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxideClose
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COMPARE TO the Active Ingredient of Tylenol® 8HR
8 Hour Pain Relief
Acetaminophen Extended-Release Tablets, 650 mg
Pain Reliever / Fever Reducer
For Up to 8 Hour Relief of Minor Muscle Aches and Pain
Minor Pain of Arthritis
650 mg EACH
- INGREDIENTS AND APPEARANCE
8 HOUR PAIN RELIEF
acetaminophen tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-217 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape CAPSULE Size 19mm Flavor Imprint Code L217 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-217-71 1 in 1 CARTON 1 50 in 1 BOTTLE 2 NDC:42507-217-78 1 in 1 CARTON 2 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075077 09/23/2005 Labeler - HyVee Inc (006925671)