Acetaminophen Caplets
Acetaminophen · Tablet · Oral
Active ingredient
Act ive ingredient (in each caplet) Acetaminophen 500 mg
Purpose
Purpose Pain reliever/fever reducer
Uses
Uses _ temporarily relieves minor aches and pains due to: _ headache _ the common cold _ backache _ minor pain of arthritis _ toothache _ muscular aches _ premenstrual and menstrual cramps _ temporarily reduces fever Drug Facts (continued)
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take _ more than 4,000 mg of acetaminophen in 24 hours _ 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: _ rash _ blisters _ skin reddening If a skin reaction occurs, stop use and seek medical help right away. Do not use _ if you are allergic to acetaminophen or any of the inactive ingredients in this product _ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug Drug Facts (continued) contains acetaminophen, ask a doctor or pharmacist. 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is Drug Facts (continued) critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not use
Do not use _ if you are allergic to acetaminophen or any of the inactive ingredients in this product _ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug Drug Facts (continued) contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is Drug Facts (continued) critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions _ do not take more than directed _ adults and children 12 years and over _ take 2 caplets every 6 hours while symptoms last _ do not take more than 6 caplets in 24 hours, unless directed by a doctor _ do not take for more than 10 days unless directed by a doctor _ children under 12 years: ask a doctor
Inactive ingredients
Inactive ingredients castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid
Questions?
Questions or comments? 1-800-901-2420 Dist. by Breeden Brothers, LLC Nashville, TN 37219
Label text from the FDA structured product label by Breeden Brothers, LLC (revised Feb 15, 2017). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
Acetaminophen Caplets NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70729-001 | Acetaminophen 500 mg/1 Tablet | Breeden Brothers, LLC | OTC MONOGRAPH NOT FINAL |
| 70729-175 | Acetaminophen 500 mg/1 Tablet | Breeden Brothers, LLC | OTC MONOGRAPH NOT FINAL |
Frequently asked questions
What is Acetaminophen Caplets used for?
Uses _ temporarily relieves minor aches and pains due to: _ headache _ the common cold _ backache _ minor pain of arthritis _ toothache _ muscular aches _ premenstrual and menstrual cramps _ temporarily reduces fever Drug Facts (continued)
Who makes Acetaminophen Caplets?
Acetaminophen Caplets is listed by 1 labeler in the FDA NDC directory, including Breeden Brothers, LLC.