5427-Major
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/ Fever reducer
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
- 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
OTC - DO NOT USE SECTION
- 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets 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
- do not take more than directed (see overdose warning)
Other Information
store in a dry place at 15° – 30°C (59° – 86°F).
INACTIVE INGREDIENT SECTION
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
MAJOR® PHARMACEUTICALS Indianapolis, IN 46268
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
HOW SUPPLIED
Acetaminophen Tablets 500 mg
Repackaged/Relabeled by:Bryant Ranch Prepack, Inc.Burbank, CA 91504
- NDC: 71335-1536-1: 20 Tablets in a BOTTLE
- NDC: 71335-1536-2: 15 Tablets in a BOTTLE
- NDC: 71335-1536-3: 40 Tablets in a BOTTLE
- NDC: 71335-1536-4: 100 Tablets in a BOTTLE
- NDC: 71335-1536-5: 30 Tablets in a BOTTLE
- NDC: 71335-1536-6: 45 Tablets in a BOTTLE
- NDC: 71335-1536-7: 50 Tablets in a BOTTLE
- NDC: 71335-1536-8: 60 Tablets in a BOTTLE
- NDC: 71335-1536-9: 90 Tablets in a BOTTLE
- NDC: 71335-1536-0: 250 Tablets in a BOTTLE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Acetaminophen Tablets 500 mg