ANACIN- aspirin and caffeine tablet 
Insight Pharmaceuticals

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 (per tablet)

Aspirin (NSAID)1 400 mg
Caffeine 32 mg


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • arthritis
  • a cold
  • toothache
  • muscular aches
  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinner (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (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 you have

  • asthma
  • ulcers
  • bleeding problems
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • 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.
  • new symptoms occur
  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • 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 over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

Keep carton for full drug facts. Read all warnings and directions before use. Store at 20° – 25°C (68°– 77°F). Protect from moisture.

Inactive ingredients

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

Distr. by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

Questions?

Call 1-800-344-7239 or visit our website at www.anacin.com

PRINCIPAL DISPLAY PANEL - sample pouch

PACKAGING NOT CHILD RESISTANT
64775C

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

2 Coated TABLETS

USES: For the temporary relief of minor aches and pains associated with headache, a cold, muscular aches,
backache, toothache, menstrual cramps and the minor pain of arthritis.
DIRECTIONS: Adults and children 12 years of age and over: 2 tablets with a full glass of water every 6 hours
while symptoms persist, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Do not give to children
under 12 years of age. Store at room temperature between 20°C - 25°C (68°F - 77°F). Protect from moisture.
ACTIVE INGREDIENTS: Each tablet contains Aspirin 400 mg, Caffeine 32 mg.
INACTIVE INGREDIENTS: Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol,
Sodium Lauryl Sulfate, Starch.

Principle Display Panel - front pouch
Principle Display Panel - back pouch

PRINCIPAL DISPLAY PANEL - 30 Count Tablets

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

30 COATED
TABLETS

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principle Display Panel - 30 Count Tablets

PRINCIPAL DISPLAY PANEL - 50 Count Tablets

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

50 COATED
TABLETS

Principle Display Panel - 50 Count Tablets

PRINCIPAL DISPLAY PANEL - 100 Count Tablets

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

100 COATED
TABLETS

Principle Display Panel - 100 Count Tablets

PRINCIPAL DISPLAY PANEL - 130 Count Tablets

BONUS OFFER
130 Tablets
For the price
of 100
Tablets

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

130 COATED
TABLETS

Principle Display Panel - 130 Count Tablets

PRINCIPAL DISPLAY PANEL - 300 Count Tablets

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

• TRUSTED  • SAFE
• EFFECTIVE

300 COATED
TABLETS

Principle Display Panel - 300 Count Tablets
ANACIN 
asprin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin40 mg
Caffeine (Caffeine) Caffeine32 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose 
cellulose, microcrystalline 
sodium lauryl sulfate 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-200-301 in 1 BOX
130 in 1 BOTTLE
2NDC:63736-200-501 in 1 BOX
250 in 1 BOTTLE
3NDC:63736-200-901 in 1 BOX
3100 in 1 BOTTLE
4NDC:63736-200-911 in 1 BOX
4130 in 1 BOTTLE
5NDC:63736-200-92125 in 1 BOX
51 in 1 POUCH
6NDC:63736-200-931 in 1 BOX
6300 in 1 BOTTLE
7NDC:63736-200-95750 in 1 BOX
71 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/25/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 06/2009
 
Insight Pharmaceuticals