Atamel Forte by RAPHA HEALTH NETWORK INTERNATIONAL INC Atamel Forte

Drug Details [pdf]

ATAMEL FORTE- acetaminophen tablet
RAPHA HEALTH NETWORK INTERNATIONAL INC

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Atamel Forte

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg *Nonsteroidal antiinflammatory drug

Purpose

Pain reliever/fever reducer aid

Uses:

for the temporary relief of minor aches and pains as recommended by your doctor. Because of delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Muscular aches. Ask your doctor for other uses for this product.

Warnings:

This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen 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 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. Liver warning:Allergy alert:

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.

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 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 the reach of children.

Overdose warning: Taking more than the 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.

Directions

Take with a full glass of water do not take more than directed Do not take more than 6 tablets in 24 hours


Adults and children over 12 years of age	Take 2 tablets every 6 hours, not more than 6 tablets in 24 hours
Children under 12 years of age	Ask a doctor

Other information

store at room temperature between 20ºC - 25ºC (68ºF to 77ºF) Read all information before using this product. Keep this box for important information

DO NOT USE IF CARTON IS OPENED AND/OR SAFETY SEAL IS BROKEN OR MISSING

Inactive ingredients

Colloidal silicon dioxide, sodium croscarmellose, magnesium stearate, corn starch, microcrystalline cellulose

Package Labeling:

Label

ATAMEL FORTE
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78527-014
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	APAP;500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 78527-014-01	3 in 1 BOX	07/01/2022	09/05/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	07/01/2022	09/05/2024

Labeler - RAPHA HEALTH NETWORK INTERNATIONAL INC (111018998)

Name	Address	ID/FEI	Business Operations
Establishment
RAPHA HEALTH NETWORK INTERNATIONAL INC		111018998	manufacture(78527-014)

Revised: 12/2023

Document Id: 0d006218-648b-0b73-e063-6394a90a1075

Set id: 2d1743de-7a56-4a06-8e31-5a330bd43bd2

Version: 3

Effective Time: 20231221