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Physicians Care Extra Strength Pain Reliever

Dosage form: tablet, film coated
Ingredients: ASPIRIN 250mg, ACETAMINOPHEN 250mg, CAFFEINE 65mg
Labeler: Acme United Corporation
NDC Code: 0924-0130

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.

Physicians Care Extra Strength Pain Reliever

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Uses

For the temporary relief of minor aches and pauns associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • back pain
  • common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever.

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:

■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

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

■ skin reddening ■ blisters ■ rash

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

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

  • more than 4,0000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning: The recommended dose of th

is product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

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 pain for more than 10 days unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you ever have had an allergic reaction to any other pain relievers/ fever reducers
  • right before or after heart surgery
  • if you are taking prescription drugs for gout, diabetes, or arthritis

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have a history of stomach problems such as heartburn
  • you have asthma

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • symptoms do not improve
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast feeding,

ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 for children even if do not notice any signs or symptoms.

Directions
  • do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information
  • read all product information before using
  • store at room temperature 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-835-2263

Physicians Care XS Pain Reliever Label

Physicians Care®

Exra Srength

Pain Reliver

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

Coated Tablets

Tamper-Evident Packets of 2 Tablets

100 Tablets (50 Packets, 2 each)

PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER 
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0130
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN250 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
MALTODEXTRIN 
HYPROMELLOSES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeFR;9
Contains    
Packaging
#Item CodePackage Description
1NDC:0924-0130-0150 PACKET in 1 CARTON
12 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/27/2013
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIOperations
Prestige Packaging170837962repack(0924-0130), relabel(0924-0130)

 
Acme United Corporation

Medically reviewed on Apr 24, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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