PAIN RELIEF BACK AND BODY EXTRA STRENGTH- 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), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Rite Aid Corporation
INN (International Name):
ASPIRIN
Composition:
ASPIRIN 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Pain reliever aid  for the temporary relief of: - backache pain - muscle aches and pains - minor aches and pains of arthritis 
Authorization status:
OTC monograph not final
Authorization number:
11822-4130-2, 11822-4130-5

PAIN RELIEF BACK AND BODY EXTRA STRENGTH- aspirin, caffeine tablet, film coated

Rite Aid 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.

----------

Rite Aid 44-413

Active ingredients (in each caplet)

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

for the temporary relief of:

backache pain

muscle aches and pains

minor aches and pains of arthritis

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 may cause a severe allergic reaction, which may include:

hives

facial swelling

shock

asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you:

take more or for a longer time than directed

take a blood thinning (anticoagulant) or steroid drug

are age 60 or older

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

have had stomach ulcers or bleeding problems

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you have asthma

you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout

diabetes

arthritis

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

an allergic reaction occurs. Seek medical help right away.

new symptoms occur

ringing in the ears or loss of hearing occurs

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health 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 (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose

adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24

hours

children under 12 years: do not use unless directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl

sulfate

Questions or Comments?

1-800-426-9391

Principal display panel

Rite

Aid®

**Compare to the active ingredients in Bayer® Back & Body

EXTRA STRENGTH

pain relief

back & body

aspirin (NSAID) and caffeine

pain reliever/pain reliever aid

100 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

trademark Bayer® Back & Body.

50844 ORG011341312

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

PHARMACY

Rite Aid 4 4 -4 13

PAIN RELIEF BACK AND BODY EXTRA STRENGTH

aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:118 22-4130

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

50 0 mg

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

CAFFEINE

32.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

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

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

44;413

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:118 22-4130 -5

1 in 1 CARTON

0 4/12/20 0 4

11/15/20 20

1

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:118 22-4130 -2

1 in 1 CARTON

0 4/12/20 0 4

10 /0 1/20 22

2

10 0 in 1 BOTTLE; 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 MONOGRAPH NOT FINAL part343

0 4/12/20 0 4

10 /0 1/20 22

Labeler -

Rite Aid Corporation (014578892)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(118 22-4130 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(118 22-4130 )

Rite Aid Corporation

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(118 22-4130 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(118 22-4130 )

Revised: 4/2020

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