BACKAID MAX- acetaminophen, pamabrom tablet, film coated

BackAid by

Drug Labeling and Warnings

BackAid by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen, 500 mg

Pamabrom, 25 mg

Purpose

Analgesic (pain reliever)

Diuretic

Uses

For the temporary relief of:

• minor aches, pains and related discomforts due to muscle strain, spasms or overexertion including those affecting the back, legs and joints
• pressure-caused discomforts due to periodic excess water retention

Warnings

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

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

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

• skin reddening
• blisters
• rash

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

DO NOT USE

Do not use

• 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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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. Use only as directed.
• Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
• Do not exceed recommended dosage.
• For use by normally healthy adults only.
• Persons under 18 years of age should use only as directed by a doctor.

Other information

• Magnesium content: 5 mg/caplet
• **CONTENTS SEALED: Each BACKAID MAX golden­-colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if 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 INGREDIENT

Inactive ingredients Calcium sulfate, croscarmellose sodium, D&C yellow #10 Lake, FD&C yellow #6 Lake, hypromellose, magnesium oxide, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, talc, titanium dioxide.

QUESTIONS

Questions?  1-800-792-2582.

Package insert

Aspirin Free

Backache Relief

BACKAID Max

1000 mg Strong per 2 Caplet Dose

Maximum Strength 6 Hour Formula

Active ingredients: Each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and pamabrom 25 mg (diuretic).

Uses: For the temporary relief of: minor aches, pains and related discomforts due to muscle strain, spasms or overexertion including those affecting the back, legs and joints. pressure-caused discomforts due to periodic excess water retention.

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum dally amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include skin reddening blisters rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse

If pregnant or breast feeding, ask a health professional before use.

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. Use only as directed.
• Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
• Do not exceed recommended dosage.
• For use by normally healthy adults only.
• Persons under 18 years of age should use only as directed by a doctor.

Other information:

Magnesium content: 5 mg/caplet

**CONTENTS SEALED: Each BACKAID MAX golden-­colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if 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 Calcium sulfate, croscarmellose sodium, D&C yellow #10 Lake, FD&C yellow #6 Lake, hypromellose, magnesium oxide, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, talc and titanium dioxide.

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACKAID  MAX
acetaminophen, pamabrom tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM GLUCONATE (UNII: 12H3K5QKN9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	orange (Goldenrod)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-153-28	2 in 1 CARTON	03/01/2011
1	NDC: 52389-153-01	14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-153-14	1 in 1 CARTON	06/01/2011
2	NDC: 52389-153-01	14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 52389-153-38	1 in 1 CARTON	09/01/2010
3	NDC: 52389-153-03	38 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 52389-153-46	1 in 1 CARTON	04/29/2016
4		46 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 52389-153-35	5 in 1 CARTON	06/01/2011
5		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/01/1992

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)