CITRAMON- aspirin acetaminophen caffeine tablet
Borisovskiy Zavod Medicinskikh Preparatov JSC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug facts

Active ingredients

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Purpose

Analgetic - antipyretic

Uses

Effective in mild to moderate intensity pain (including headache, migraine, toothache, pain in osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, myalgia) and fever syndrome in acute infectious, infectious inflammatory diseases.

Warnings

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Prompt medical attention is critical even if you do not notice any signs or symptons.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center immediately.

Directions

Adults and children over 15 years take 1 tablet 2 - 3 times a day. The interval between the drug intakes should be at least 6 - 8 hours. Maximum single dose is 2 tablets, maximum daily dose is 4 tablets.

Other information

Keep in a dry place at temperature below 77 ºF (25 ºC).

Inactive ingredients

Cocoa, Citric acid monohydrate, Potato starch, Talc, Stearic acid.

image of paper blister image of group label

CITRAMON
aspirin acetaminophen caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16638-118
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	220 mg in 550 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg in 550 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	27 mg in 550 mg

Ingredient Name	Strength
Inactive Ingredients
COCOA (UNII: D9108TZ9KG)	22.5 mg in 550 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	4.6 mg in 550 mg
STARCH, POTATO (UNII: 8I089SAH3T)	68 mg in 550 mg
TALC (UNII: 7SEV7J4R1U)	2.4 mg in 550 mg
STEARIC ACID (UNII: 4ELV7Z65AP)	7.15 mg in 550 mg

Product Characteristics
Color	brown (Light brown with white inclusions)	Score	2 pieces
Shape	ROUND (Tablet)	Size	12mm
Flavor	COFFEE (Coffee flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16638-118-13	3300 mg in 1 PACKAGE; Type 0: Not a Combination Product	09/11/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/26/1996

Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)

Name	Address	ID/FEI	Business Operations
Establishment
Borisovskiy Zavod Medicinskikh Preparatov JSC		628149593	manufacture(16638-118)