ANACIN- asprin and caffeine tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Insight Pharmaceuticals LLC
INN (International Name):
ASPIRIN
Composition:
ASPIRIN 400 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever aid temporarily relieves minor aches and pains due to - Headache - toothache - muscular aches - a cold - backache - arthritis - menstrual cramps
Authorization status:
OTC monograph not final
Authorization number:
63736-200-04, 63736-200-30, 63736-200-50, 63736-200-90, 63736-200-91, 63736-200-92, 63736-200-93, 63736-200-95

ANACIN- asprin and caffeine tablet

Insight Pharmaceuticals LLC

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.

----------

Anacin - 63736-200

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN

Drug Facts

Active ingredients (per tablet)

Aspirin (NSAID)* 400 mg

Caffeine 32 mg

* nonsteroidal anti- inflammatory drug

Purposes

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to

Headache

toothache

muscular aches

a cold

backache

arthritis

menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this product. When using this product, if changes in behavior with nausea and

vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a

rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

Stomach bleeding warning

®

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinner (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,

or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a

diuretic

you have asthma

Ask a doctor or pharmacist before use if

you are taking a prescription drug for diabetes, gout, or arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs of stomach bleeding

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

new symptoms occur

ringing in the ears or loss of hearing occurs

redness or swelling is present

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the

use of caffeine-containing medications, foods or beverages while taking this product because too much

caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months

of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the

unborn child or complications during delivery.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not use more than directed (see overdose warning)

drink a full glass of water with each dose

adults and children 12 years of age and older: take 2 tablets every 6 hours; not more than 8 tablets in

24 hours, or as directed by a doctor

children under 12 years of age: do not use

Other information

Keep carton for full drug facts and warnings.

Store at 15 – 25°C (59– 77°F). Protect from moisture.

Inactive ingredients

corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Questions?

1-800-344-7239 anacin.com

PRINCIPAL DISPLAY PANEL

ANACIN

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

ANACIN

asprin and caffeine tablet

Product Information

®

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 3736 -20 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

40 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

32 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 3736 -20 0 -0 4

1 in 1 BOX

0 6 /25/20 0 9

0 6 /30 /20 23

1

4 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 3736 -20 0 -9 3

1 in 1 BOX

0 6 /25/20 0 9

2

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:6 3736 -20 0 -30

1 in 1 BOX

0 6 /25/20 0 9

0 6 /30 /20 23

3

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:6 3736 -20 0 -50

1 in 1 BOX

0 6 /25/20 0 9

4

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:6 3736 -20 0 -9 0

1 in 1 BOX

0 6 /25/20 0 9

5

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:6 3736 -20 0 -9 1

1 in 1 BOX

0 6 /25/20 0 9

0 6 /30 /20 23

6

130 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:6 3736 -20 0 -9 2

125 in 1 BOX

0 6 /25/20 0 9

7

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:6 3736 -20 0 -9 5

750 in 1 BOX

0 6 /25/20 0 9

0 6 /30 /20 23

8

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

Insight Pharmaceuticals LLC

OTC MONOGRAPH NOT FINAL part343

0 6 /25/20 0 9

Labeler -

Insight Pharmaceuticals LLC (055665422)

Revised: 7/2020

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