Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

do not take more than directed (see overdose warning).

adult and children 12 years and over	take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	Ask a doctor

Other information

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
store between 20-250C (68-770F)

Inactive ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions?

Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

HOW SUPPLIED

Product: 50090-0395

NDC: 50090-0395-0 15 TABLET in a BOTTLE

NDC: 50090-0395-1 30 TABLET in a BOTTLE

NDC: 50090-0395-2 100 TABLET in a BOTTLE

NDC: 50090-0395-3 50 TABLET in a BOTTLE

NDC: 50090-0395-4 24 TABLET in a BOTTLE

NDC: 50090-0395-5 20 TABLET in a BOTTLE

NDC: 50090-0395-8 2 TABLET in a BOTTLE

Acetaminophen

PHARBETOL
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-0395(NDC:16103-376)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	PH044
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-0395-8	2 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2017
2	NDC:50090-0395-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
3	NDC:50090-0395-5	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
4	NDC:50090-0395-0	15 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
5	NDC:50090-0395-3	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
6	NDC:50090-0395-4	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
7	NDC:50090-0395-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	01/10/2006

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-0395) , REPACK(50090-0395)

Drug Facts