Active Ingredients And Purpose
Active ingredient (in each caplet)
Acetaminophen USP, 650 mg
Purpose
Pain reliever/fever reducer
Acetaminophen
- Manufacturer
- MEIJER, INC.
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:30
Key Label Information#
Uses
Uses
■ temporarily relieves minor aches and pains due to: ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ premenstrual and menstrual cramps ■ headache ■ the common cold ■ temporarily reduces fever
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
Ask a doctor before use if you have
liver disease
Directions And Dosage
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.
Directions
■ do not take more than directed (see overdose warning) adults and children ■ 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 12 years of age and over children under 12 years ■ do not use
Other Label Information
Other information
■ store between 20-25°C (68-77°F) ■ do not use if foil inner seal is broken or missing
Inactive ingredients
hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
PDP
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 7 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 7 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 7 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 7 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79481-0184-1 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 7 | |
| 79481-0184-8 | Acetaminophen | 24 in 1 BOTTLE | TABLET | 24 | 7 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79481-0184 | 79481-0184-8, 79481-0184-1 |
Ingredients#
Complete SPL Sections#
Active ingredient (in each caplet)
Acetaminophen USP, 650 mg
Purpose
Pain reliever/fever reducer
Uses
■ temporarily relieves minor aches and pains due to: ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ premenstrual and menstrual cramps ■ headache ■ the common cold ■ 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 ■ 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
Ask a doctor before use if you have
liver disease
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
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.
Directions
■ do not take more than directed (see overdose warning) adults and children ■ 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 12 years of age and over children under 12 years ■ do not use
Other information
■ store between 20-25°C (68-77°F) ■ do not use if foil inner seal is broken or missing
Inactive ingredients
hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST