BACKAID INFLAMMATORY PAIN FORMULA acetaminophen aspirin caffeine tablet film coated

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

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Active ingredient:
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)
Available from:
Alva-Amco Pharmacal Companies, Inc.
INN (International Name):
Acetaminophen
Composition:
Acetaminophen 250 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

BACKAID INFLAMMATORY PAIN FORMULA- acetaminophen, aspirin, caffeine tablet, film

coated

Alva-Amco Pharmacal Companies, Inc.

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.

----------

Drug Facts

Active ingredients (in each caplet)

Acetaminophen, 250 mg

Aspirin (NSAID)*, 250 mg

Caffeine Anhydrous, 65 mg

*Non-steroidal anti-inflammatory drug

Purpos e

Analgesic (pain reliever)

Uses For the temporary relief of minor aches and pains including the minor pain 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

asthma (wheezing)

shock

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

more than 8 caplets in 24 hours, which is the maximum daily amount

with other products containing acetaminophen

3 or more alcoholic drinks every day while using this product.

Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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 (anti-coagulant) 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.

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 disease, liver cirrhosis or kidney disease

you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

taking any other drug.

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present.

ringing in the ears or hearing loss occurs.

any new symptoms occur

you experience any of the following signs of stomach bleeding:

you feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use

aspirin during the last 3 months of pregnancy unless definitely directed 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 you do

not notice any signs or symptoms.

Directions

Read all package directions and warnings before use and use only as directed.

Adults: Two (2) caplets every 6 hours while symptoms persist, not to exceed 4 doses (8 caplets) in

24 hours, or as directed by a doctor.

Drink a full glass of water with each dose

Intended for use by normally healthy adults only

Persons under 18 years of age should use only as directed by a doctor.

Other information

**Contents sealed: Each BACKAID IPF white colored, capsule shaped caplet bears the identifying

mark "ALVA" and a "2" on the reverse side, and is packaged in a bottle with a safety seal under the cap.

Do not use if the seal appears broken or if product contents do not match product description. You may

report serious side effects to the phone number provided under Questions? below.

Inactive ingredients: Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose,

polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide and

triglycerides.

Questions? 1-800-792-2582

BACKAID INFLAMMATORY PAIN FORMULA

acetaminophen, aspirin, caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 9 -6 22

Route of Administration

ORAL

Alva-Amco Pharmacal Companies, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

250 mg

Ca ffeine (UNII: 3G6 A5W338 E) (Caffeine - UNII:3G6 A5W338 E)

Ca ffe ine

6 5 mg

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

Aspirin

250 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Hypro mello ses (UNII: 3NXW29 V3WO)

Ma lto dextrin (UNII: 7CVR7L4A2D)

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

Po lydextro se (UNII: VH2XOU12IE)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

silico n dio xide (UNII: ETJ7Z6 XBU4)

stea ric a cid (UNII: 4ELV7Z6 5AP)

ta lc (UNII: 7SEV7J4R1U)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE (capsule-shaped caplet)

S iz e

17mm

Flavor

Imprint Code

ALVA;2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5238 9 -6 22-28

1 in 1 CARTON

1

28 in 1 BOTTLE, PLASTIC

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 /22/20 12

Labeler -

Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 10/2012

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