PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, caffeine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Acme United Corporation
INN (International Name):
ASPIRIN
Composition:
ASPIRIN 250 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Pain reliever/fever reducer Pain reliever aid 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.
Authorization status:
OTC monograph not final
Authorization number:
0924-0130-01

PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin,

caffeine tablet, film coated

Acme United Corporation

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.

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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

taking a prescription drug for gout, diabetes or arthritis

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

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?

1-800-835-2263

Physicians Care XS Pain Reliever Label

90316

Physicians Care®

Exra Srength

Pain Reliver

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

Pull To Open

This Package For Househlds Without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if package is open or torn.

100 Tablets (50 Packets, 2 tablets each)

PHYSICIANS CARE EXTRA STRENGTH PAIN RELIEVER

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 24-0 130

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

250 mg

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

250 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

Acme United Corporation

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

FR;9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 24-0 130 -0 1

50 in 1 CARTON

0 9 /27/20 13

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 9 /27/20 13

Labeler -

Acme United Corporation (001180207)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Prestige Packaging

170 8 379 6 2

repack(0 9 24-0 130 ) , relabel(0 9 24-0 130 )

Revised: 10/2019

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