MedPath

Pain Reliever

Approved
Approval ID

0c66b05d-132d-4c79-abfe-415fd68bbb9c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

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
NDC Product Code83586-107
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (11)

HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

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

LOINC: 55106-9Updated: 8/12/2025

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Pain reliever/Fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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

LOINC: 50570-1Updated: 8/12/2025

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

LOINC: 50569-3Updated: 8/12/2025

Ask a doctor before use if you have

liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 8/12/2025

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

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

LOINC: 53414-9Updated: 8/12/2025

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/12/2025

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

LOINC: 34068-7Updated: 8/12/2025

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

LOINC: 44425-7Updated: 8/12/2025

Other information

  • store at 15° to 30°C (59° to 86°F)
  • read all product information before using

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

Pregelatinized Starch, Povidone, Stearic Acid powder, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose 5 & 15, Polyethylene Glycol, Titanium Dioxide, Talc

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

Call +1 848-235-5293 Mon - Fri 9 AM - 5 PM EST

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Pain Reliever - FDA Drug Approval Details