Label: PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 0924-0128-01, 0924-0128-02, 0924-0128-03
- Packager: Acme United Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 27, 2017
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- Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mgClose
Pain reliever/fever reducerClose
For the temporary relief of minor aches and pains associated with
■ muscular aches
■ minor arthritis pain
■ common cold
■ menstrual cramps
For the reduction of fever.Close
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
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
Stop using and ask a doctor if
■ symptoms do not improve
■ new symptoms occur
■ pain or fever persists or gets worse
■ redness or swelling is present
Keep out of the 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.
■ 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 therecommended dose (overdose) and may cause liver damage.Close
- Other information
■ store at room temperature 59º-86ºF (15º-30ºC)
■ tamper-evident sealed packets
■ do not use any opened or torn packetsClose
- INACTIVE INGREDIENT
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may containClose
- Questions or comments?
- PhysiciansCare XS Non Aspirin Label
Acetaminophen Fever Reducer & Pain Reliever
Pull To Open
Tamper-Evident Packets of 2 Tablets
250 Tablets (125 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:0924-0128 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 K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0128-01 50 in 1 CARTON 01/20/2012 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-0128-02 125 in 1 CARTON 01/20/2012 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-0128-03 10 in 1 CARTON 01/20/2012 3 2 in 1 PACKET; Type 0: Not a Combination Product 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)