Extra Strength Headache Relief

Drug Labeling and Warnings

Drug Details [pdf]

EXTRA STRENGTH HEADACH RELIEF- acetaminophen, aspirin, and caffeine tablet 
Mechanical Servants LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Extra Strength Headache Relief

Drug Facts

Active ingredient (in each tablet)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Aspirin (NSAID) 250 mgPain reliever/fever reducer
Caffeine 65 mgadjuvant

Use

temporarily relieves minor aches and pains due to:

  • headache
  • colds
  • minor arthritis pain
  • muscular aches
  • toothache
  • backache
  • menstrual cramps

Warnings

Reye's syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with asprin.

Allergy alert-do not use

  • if you are allergic to asprin or any other salicylate
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Liver warning

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

  • more than 8 tablets in 24 hours,
  • with other drugs containing acetaminophen (perscription or nonperscription). Ask a doctor orpharmacist before using with other drugs if you are not sure.
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains nonsteroidal anti-inflammatory drugs (NSAIDs), which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed

Do not use

  • if you are allergic to aspirin
  • with any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to any other pain reliever-fever reducer
  • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
  • with any other product containing acetaminophen

Ask a doctor before using if you have

  • asthma
  • gastric ulcers
  • bleeding problems
  • stomach problems (such as heartburn, upset stomach or stomach pain)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • anticoagulation (thinning of blood)
  • diabetes
  • gout
  • arthritis

When using this product do not exceed recommended dose

Stop use and ask a doctor if

  • ringing in the ears or loss of hearing occurs
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

If pregnant or breast-feeding, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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 right away(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • adults and children 12 years of age and older:
    2 tablets as needed for pain every 6 hours.
    Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: ask a doctor

Other information

  • TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN, CUT OR OPENED
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide

Questions or comments?

1-844-428-2538

Manufactured by Ultratab Laboratories, Inc

Repackaged and distributed by
Convenience Valet ®, Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Package

Extra Strength

Headache

Relief

Acetaminophen

Aspirin (NSAID)

and Caffeine

Pain Reliever / Fever Reducer

COMPARE TO THE ACTIVE INGREDIENTS IN

EXCEDRIN ® Extra Strength *

6 TABLETS

Principal Display Panel - 6 Tablet Pouch Package

EXTRA STRENGTH HEADACH RELIEF 
acetaminophen, aspirin, and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 29485-0751
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code FR9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 29485-0751-33 in 1 PACKAGE01/31/201303/27/2019
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/31/201303/27/2019
Labeler - Mechanical Servants LLC (005530951)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(29485-0751) , repack(29485-0751)

Revised: 10/2019