Label: 8HR MUSCLE ACHES AND PAIN- acetaminophen tablet, extended release
- NDC Code(s): 57344-201-03
- Packager: AAA Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 13, 2024
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- SPL UNCLASSIFIED SECTION
- 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 every 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 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)
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, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years - do not use
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
Restore U
NDC 57344-201-03
†COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® 8HR MUSCLE ACHES AND PAIN
8HR Muscle Aches & Pain
Acetaminophen
Extended-Release Tablets, 650mg
Pain Reliever / Fever Reducer
For up to 8 hour relief of minor muscle aches and pain
Actual Size
100 CAPLETS** - 650 MG EACH
**Capsule-Shaped Bi-Layer Tablets
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INGREDIENTS AND APPEARANCE
8HR MUSCLE ACHES AND PAIN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-201 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 HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) 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:57344-201-03 1 in 1 CARTON 04/15/2024 1 100 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 04/15/2024 Labeler - AAA Pharmaceutical, Inc. (181192162)