PAIN AWAY PLUS acetaminophen aspirin caffeine tablet film coated

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

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Medex Merchandising LLC
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 65 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

PAIN AWAY PLUS- acetaminophen, aspirin, caffeine tablet, film coated

Medex Merchandising LLC

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.

----------

Medex Pain Away Plus

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 pains 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 (NSAID) may cause a severe allergic reaction which may include:

■ hives ■ skin reddening ■ facial swelling ■ rash ■ asthma (wheezing) ■ shock ■ blisters

If an 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 4,000 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 this 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.

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 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive ingredeints

hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch

glycolate, starch, stearic acid, titanium dioxide

Questions or comments? 1-888-753-6575

Medex Pain Away Plus PDP

Compare to the Active Ingredients in

Excedrin® Extra Strength

This box contains a generic product called Pain Away

Pain Away +Plus

20 Packets of 2 Tablets

Remove this panel

Read Drug Facts and Instructions on Packet

PAIN AWAY PLUS

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 26 -18 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

CAFFEINE

6 5 mg

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

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

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

Product Characteristics

Medex Merchandising LLC

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:6 8 8 26 -18 0 -20

20 in 1 BOX, UNIT-DOSE

10 /15/20 15

0 3/0 1/20 19

1

NDC:6 8 8 26 -18 0 -0 2

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

2

NDC:6 8 8 26 -18 0 -25

25 in 1 BOX, UNIT-DOSE

10 /15/20 15

0 3/0 1/20 19

2

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

3

NDC:6 8 8 26 -18 0 -30

30 in 1 BOX, UNIT-DOSE

10 /15/20 15

0 3/0 1/20 19

3

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

4

NDC:6 8 8 26 -18 0 -50

50 in 1 BOX, UNIT-DOSE

10 /15/20 15

0 3/0 1/20 19

4

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

5

NDC:6 8 8 26 -18 0 -75

75 in 1 BOX, UNIT-DOSE

10 /15/20 15

0 3/0 1/20 19

5

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

10 /15/20 15

0 3/0 1/20 19

Labeler -

Medex Merchandising LLC (152196630)

Registrant -

Unifirst First Aid Corporation (832947092)

Revised: 5/2017

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