NDC | 52389-153-01, 52389-153-03, 52389-153-14, 52389-153-28, 52389-153-35, 52389-153-38, 52389-153-46 |
Set ID | fb9a5647-b7c9-4820-b148-91060e34cb83 |
Category | HUMAN OTC DRUG LABEL |
Packager | Alva-Amco Pharmacal Companies, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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
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INGREDIENTS AND APPEARANCE
BACKAID MAX
acetaminophen, pamabrom tablet, film coatedProduct 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)