Pain Reliever
0c66b05d-132d-4c79-abfe-415fd68bbb9c
HUMAN OTC DRUG LABEL
Aug 12, 2025
HHH PHARMA USA LLC
DUNS: 062788820
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses:
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain from arthritis
- the common cold
- toothache
- temporarily reduces fever
- premenstrual and menstrual cramps
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/Fever reducer
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4000 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:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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.
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:
- 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.
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.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed**(see overdose warning)** *adults and children 12 years of age and over:
- take 2 caplets every 6 hours while symptoms last
- do not take mote than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
- children under 12 years of age: do not use
STORAGE AND HANDLING SECTION
Other information
- store at 15° to 30°C (59° to 86°F)
- read all product information before using
INACTIVE INGREDIENT SECTION
Inactive ingredients
Pregelatinized Starch, Povidone, Stearic Acid powder, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose 5 & 15, Polyethylene Glycol, Titanium Dioxide, Talc
OTC - QUESTIONS SECTION
Questions or comments?
Call +1 848-235-5293 Mon - Fri 9 AM - 5 PM EST