Active Ingredients And Purpose
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen USP, 650 mg
PURPOSE
Pain reliever/fever reducer
Acetaminophen
- Manufacturer
- Safeway Inc. | Ohm Laboratories Inc.
- Effective date
- 2012-09-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:33:09
Key Label Information
Uses
USES
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever
Warnings
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
Directions And Dosage
DIRECTIONS
do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew 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 18 years of age ask a doctor
Other Label Information
INACTIVE INGREDIENTS
Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
QUESTIONS?
Call 1-800-406-7984
PRINCIPAL DISPLAY PANEL
Lasts up to 8 Hours Use only as directed. NDC 21130-760-51 Arthritis Pain Relief Compare to Tylenol ® Arthritis Pain active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For The Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ™ DISTRIBUTED BY SAFEWAY INC. 5089374/R1011
Label Images
NDC Codes
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: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps 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
DIRECTIONS
do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew 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 18 years of age ask a doctor
OTHER INFORMATION
store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
INACTIVE INGREDIENTS
Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
QUESTIONS?
Call 1-800-406-7984
PRINCIPAL DISPLAY PANEL
Lasts up to 8 Hours Use only as directed. NDC 21130-760-51 Arthritis Pain Relief Compare to Tylenol ® Arthritis Pain active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For The Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ™ DISTRIBUTED BY SAFEWAY INC. 5089374/R1011
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/0eb865a6-229e-452d-a6a9-eb213018d192/0a02ebb4-0d21-4159-b143-54662c512451.xml
- XML SHA-256
- e1e602ed12215ac6e1fcb6df0de3f6d173f30ddf931aa9a913b2ab728e7d44be
- XML bytes
- 30168
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 0a02ebb4-0d21-4159-b143-54662c512451.xml | 2012-10-01 |
| otc | APAPArthritis.jpg | 2012-10-01 |