FORTOLIN- acetaminophen tablet

FORTOLIN by

Drug Labeling and Warnings

FORTOLIN by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY, LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Acetaminophen 500 mg

PURPOSE

Purpose
Pain reliever-fever reducer

INDICATIONS & USAGE

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

WARNINGS

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

Do not use
on children under 3 years of age

STOP USE

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)

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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.

INGREDIENTS AND APPEARANCE

FORTOLIN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-127
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	F;O;R;T;O;L;I;N
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-127-24	24 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2004

Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY, LIMITED		686280561	manufacture(51467-127)