PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated

PhysiciansCare Non Aspirin by

Drug Labeling and Warnings

PhysiciansCare Non Aspirin by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ common cold

■ toothache

■ menstrual cramps

temporariky 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.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

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

■ symptoms do not improve

■ new symptoms occur

■ pain or fever persists or gets worse

■ redness or swelling is present

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

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Questions?

1-800-835-2263

PhysiciansCare XS Non Aspirin Label

90016

Physicians Care®

Extra Strength

Non Aspirin

Acetaminophen Fever Reducer & Pain Reliever

This Package For Households Without Young Children.

Pull To Open

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aceatminiphen 500 mg

100 Tablets (50 Packets, 2 each)

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE NON ASPIRIN  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0123
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0123-01	50 in 1 CARTON	01/20/2012
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-0123-02	125 in 1 CARTON	01/20/2012
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-0123-03	10 in 1 CARTON	01/20/2012
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-0123-00	2 in 1 PACKET; Type 0: Not a Combination Product	01/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/20/2012

Labeler - Acme United Corporation (001180207)