ATAMEL FORTE- acetaminophen tablet, coated

ATAMEL Forte by

Drug Labeling and Warnings

ATAMEL Forte by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, HBC HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

• Acetaminophen 650 mg

Purpose

Pain reliever / Fever Reducer

Uses

• Temporarily relieves minor aches and pains due to:
• Minor pain of arthritis
• Muscular aches
• Backache
• Premenstrual and menstrual cramps
• The common cold
• Headache
• Toothache
• 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.

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

• Skin redding
• Blisters
• Rash

If skin reaction occurs, stop use and seek medical help right away.

Do not use

• With any other 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

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 sings of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

​Keep out of reach of children

Keep out of reach of children

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 sings or symptoms.

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, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by doctor
• Under 18 years of age:
  • Ask a doctor

Other information

• Store between 20-25°C (60-77°F)
• Do not use if carton is opened.
• Do not use if foil inner seal is broken or missing.

Inactive ingredients

caranuba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin.

Questions or comments?

Call (619)600-5632 (Mon-Fri 9am - 5pm PST)

SPL UNCLASSIFIED SECTION

Made for:

San Diego, CA 92154

Exclusivey distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL

NDC: 69729-800-24

Acetaminophen 650 mg

Atamel®

Via de Administracion: Oral

Forte

Alivia el Dolor

Pain Relief

Reduce la fiebre

Fever Reducer

Dolores Musculares

Muscles Aches

Dolor de cabeza

Headache

Dolor leve por Artritis

Minor Pain of Arthritis

24 Caplets

INGREDIENTS AND APPEARANCE

ATAMEL FORTE 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-800
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TRIACETIN (UNII: XHX3C3X673)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Oblong)	Size	21mm
Flavor		Imprint Code	OPMX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-800-24	2 in 1 CARTON	01/29/2026
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/29/2026

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
HBC HEALTHCARE PRIVATE LIMITED		854255181	manufacture(69729-800)