MIGRAINE RELIEF- acetaminophen, aspirin, caffeine tablet 
Family Dollar (FAMILY WELLNESS)

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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

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: Acetaminophen may cause severe reactions Symptoms may include:

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

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Medication overuse headache warning: Headaches may worsen. If this product is used for 10 or more days per mounth.

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.

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

  • you have never had migraines diagnosed by a health professional 
  • you have a headache that is different from you usual migraine
  • you have the worst headache of your life  
  • you have fever and stiff neck 
  • you have headaches beginning after or caused by head injury, exertion, coughing, bending
  • you experienced your first headache after the age of 50
  • you have daily headaches
  • you have a migraine so severe as to require bed rest
  • you have liver disease
  • stomach bleeding warnings applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
    • diabetes,
    • gout,
    • arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Stop use and ask doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding 
    • feel faint
    • vomit blood
    • have bloody or black stool
    • have stomach pain that does not get better
  • your migraine is not relieved or worsens after first dose
  • new or unexpected symptoms occur
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose,  polyethylene glycol, sodium stearyl fumarate, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® MIGRAINE†

MIGRAINE RELIEF

Acetaminophen Aspirin and Caffeine Tablets, USP

250 mg, 250 mg and 65 mg

Pain reliever/Pain reliever aid

CAPLETS**

(**Capsule-shaped tablets)

†This product is not manufactured or distributed by GSK Consumer Healthcare Holdings (US) LLC, distributor of Excedrin® Migraine

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

MIDWOOD BRANDS, LLC

500 VOLVO PKWY,

CHESAPEAKE, VA 23320

Package Label

Acetaminophen 250 mg, Aspirin 250 mg (NSAID*), Caffeine 65 mg, *nonsteroidal anti-inflammatory drug

FAMILY WELLNESS Migraine Relief

MIGRAINE RELIEF 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-970(NDC:62207-680)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Capsule shaped Tablet) Size17mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-970-241 in 1 BOX07/01/2023
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:55319-970-101 in 1 BOX07/01/2023
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21403907/01/2023
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 8/2023
Document Id: a0a2bde5-641e-44f0-b9a1-b57dd0993325
Set id: bfcffa70-94a9-43de-9f22-4ed6a71c0a8d
Version: 2
Effective Time: 20230825
 
Family Dollar (FAMILY WELLNESS)