BACKAID- acetaminophen, caffeine tablet, film coated

BackAid by

Drug Labeling and Warnings

BackAid by is a Otc medication manufactured, distributed, or labeled by Kobayashi Healthcare International, Inc., Kobayashi America Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen, 500 mg

Caffeine, 75 mg

Purpose

Analgesic (pain reliever)

Analgesic aid

Uses

For the temporary relief of minor aches and pains associated with

• backache
• muscular aches
• headache

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.

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.

WHEN USING

When using this product, limit the use of caffeine-containing medications, foods or beverages because too mush caffeine may cause

• nervousness
• irritability
• sleeplessness
• occasional rapid heartbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• any new symptoms appear

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

**CONTENTS SEALED: Each BACKAID white­ 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

Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Questions?

1-800-792-2582.

Package insert

New & Improved Formula

Maximum Strength

BACKAID

6 Hour Formula

Acetaminophen + Caffeine

• Eases Pain of Inflammation
• Relieves Backache and Sciatica Pain

Active ingredients: Each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and caffeine anhydrous 75 mg (analgesic aid).

Uses: For the temporary relief of minor aches and pains associated with backache muscular aches headache

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.

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.

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much cafeine may cause

• nervousness
• irritability
• sleeplessness
• occassional rapid heatbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or welling is present
• any new symptoms appear

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:

**CONTENTS SEALED: Each BACKAID white colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing or in a bottle with a safety seal under the cap. 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 Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Questions? 1-800-792-2582

Fórmula nueva y mejorada

Maxima concentración

BACKAID

Fórmula de 6 horas

Acetaminofeno + cafeina

• Alivia el dolor de la inflamación
• Alivia el dolor de espalda y el dolor ciático

Ingredientes activos: Cada comprimido oblongo contiene: 500 mg de acetaminofeno (un analgésico, alivia el dolor) y 75 mg de cafeína anhidra (ayuda analgésica).

Usos: Para el alivio temporal de dolores menores asociados con

• dolor de espalda
• dolores musculares
• dolor de cabeza

Advertencias:

Advertencia hepática: Este producto contiene acetaminofeno. Puede producirse un daño hepático grave si usted toma:

• más de 6 comprimidos oblongos en 24 horas, que es la cantidad diaria máxima
• otros fármacos que contienen acetaminofeno al mismo tiempo
• 3 o más bebidas alcohólicas cada día mientras usa este producto.

Alerta de alergias: El acetaminofeno puede causar reacciones graves en la piel. Los síntomas pueden incluir:

• enrojecimiento de la piel
• ampollas
• sarpullido

Si se produce una reacción en la piel, deje de usar el producto y busque ayuda médica de inmediato.

No lo use

• con ningún otro fármaco que contenga acetaminofeno (de venta con receta o sin ella). Si no está seguro respecto de si un fármaco contiene acetaminofeno o no, pregúntele a un médico o farmacéutico.

Pregúntele a un médico antes de usarlo si tiene enfermedad hepática.

Pregúntele a un médico o farmacéutico antes de usarlo si está tomando el fármaco anticoagulante warfarina.

Cuando use este producto, limite el uso de medicamentos, alimentos o bebidas que contengan cafeína ya que demasiada cafeína puede provocar:

• nerviosismo
• irritabilidad
• insomnio
• latidos cardíacos rápidos ocasionales

La dosis recomendada de este producto contiene aproximadamente la misma cantidad de cafeína que una taza y media de café.

Deje de usarlo y consulte a un médico si

• el dolor empeora o dura más de 10 días
• la fiebre empeora o dura más de 3 días
• aparece enrojecimiento o hinchazón
• se presentan síntomas nuevos.

Si está embarazada o está amamantando, consulte a un profesional de la salud antes de usarlo.

Manténgalo fuera del alcance de los niños. En caso de sobredosis, obtenga ayuda médica o comuníquese de inmediato con un centro de toxicología. La atención médica inmediata es fundamental tanto para los adultos como para los niños, incluso si no observa signos ni síntomas.

Indicaciones:

• Lea todas las indicaciones y advertencias del envase antes de usarlo. Usar según indicaciones.
• Adultos: Dos (2) comprimidos oblongos con un vaso lleno de agua cada 6 horas mientras los síntomas persisten, sin exceder las 3 dosis (6 comprimidos oblongos) en 24 horas, o según lo indique un médico.
• No exceda la dosificación recomendada.
• Para uso por parte de adultos normalmente sanos únicamente.
• Las personas menores de 18 años deben usarlo solo según las indicaciones de un médico.

Información adicional:

• **CONTENIDO SELLADO: Cada comprimido de BACKAID, de forma ovalada y color blanco, lleva la marca identificatoria “ALVA” y está sellado en un blíster de plástico transparente con un recubrimiento posterior de papel/aluminio, o en un frasco con un sello de seguridad debajo de la tapa. No lo use si el sello parece estar roto o si el contenido del producto no coincide con la descripción del producto.
• Puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿Tiene preguntas? a continuación.

Ingredientes inactivos: almidón de maíz, croscarmelosa sódica, hipromelosa, maltodextrina, celulosa microcristalina, polidextrosa, povidona, dióxido de silicio, ácido esteárico, talco, dióxido de titanio, triglicéridos.

¿Tiene preguntas? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACKAID 
acetaminophen, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-253
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	75 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	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: 52389-253-28	2 in 1 CARTON	12/11/2024
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-253-14	1 in 1 CARTON	12/11/2024
2		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 52389-253-38	1 in 1 CARTON	12/11/2024
3		38 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	10/31/2024

Labeler - Kobayashi Healthcare International, Inc. (156391729)

Registrant - Kobayashi America Manufacturing, LLC (079852150)