Migrafein Forte

Migrafein Forte
SPL v2
SPL
SPL Set ID 028875c9-4129-ce2c-e063-6294a90a26cc
Route
ORAL
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Starch, Corn Povidone, Unspecified Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Yellow No. 6 Magnesium Stearate Polyethylene Glycol, Unspecified Titanium Dioxide Talc Stearic Acid D&c Red No. 27 Silicon Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 5431 Shape: oval Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-09

Description

Acetaminophen 500 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Uses
  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches
Purposes

Pain reliever

Pain reliever aid

Directions
  • do not exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
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
Caffeine Warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

Questions Or Comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Principal Display Panel

NDC 69729-148-40

Migrafein FORTE

40 Caplets

Ask A Doctor Before Use If

you have liver disease

Ask A Doctor Or Pharmacist

if you are taking the blood thinning drug warfarin

Stop Use and Ask A Doctor If
  • any new symptoms occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Caffeine 65 mg


Structured Label Content

Uses
  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches
Purposes

Pain reliever

Pain reliever aid

Directions
  • do not exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
Liver Warning (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
Caffeine Warning (Caffeine warning)

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Principal Display Panel

NDC 69729-148-40

Migrafein FORTE

40 Caplets

Ask A Doctor Before Use If (Ask a doctor before use if)

you have liver disease

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

if you are taking the blood thinning drug warfarin

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • any new symptoms occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
If Pregnant 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 65 mg


Advanced Ingredient Data


Raw Label Data

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