FORTOLIN- acetaminophen tablet 
FORTUNE PHARMACAL COMPANY, LIMITED

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.

----------

Drug Facts

Active ingredients
Acetaminophen 500 mg

Purpose
Pain reliever-fever reducer

Uses
For the temporary relief of minor aches and pains associated with the common cold
headache
toothache
muscular aches
To reduce fever

Warnings Alcohol warning:
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or otehr pain relievers/fever reducers.
Acetaminophen may cause liver damage

Do not use
on children under 3 years of age

Stop use and ask a doctor if
you need to use this product for pain for mroe than 10 days
fever lasts for more than 3 days (72 hours) or ets worse
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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions
Take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age : consult a docto

Other information
Each tablet contains sodium 0.496 mg
Keep tightly closed
Store in original packaging, away from sunlight

Inactive ingredients
colloidal silicon dioxide, corn starch, lactose, magnesium stearate, povidone, sodium starch glycolate

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm PST

Fortolin

Pain Reliever Fever Reducer

NDC 51467-127-24

Aspirin Free

Contain no aspirin and are unlikely to cause gastric irritation.

Acetaminophen 500 mg

24 Tablets

Safety Sealed

Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

Box1

FORTOLIN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code F;O;R;T;O;L;I;N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51467-127-2424 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/2004
Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY, LIMITED686280561manufacture(51467-127)

Revised: 6/2014
Document Id: b5f2af89-8122-4675-af32-0223b66865c0
Set id: 5d55e4c0-e573-42f1-8f7b-87dda7821cd9
Version: 1
Effective Time: 20140623
 
FORTUNE PHARMACAL COMPANY, LIMITED