EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet

Extra Strength Headache Relief by

Drug Labeling and Warnings

Extra Strength Headache Relief by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)	Purposes
Acetaminophen 250 mg	Pain reliever/fever reducer
Aspirin (NSAID)* 250 mg	Pain reliever/fever reducer
Caffeine 65 mg	Pain reliever aid

* nonsteroidal anti-inflammatory drug

Use

temporarily relieves minor aches and pains due to:

backache
headaches
colds
muscular aches
minor arthritis pain
menstrual cramps
Temporarily reduces fever.

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 behaviour 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:

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

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.

Liver warning

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

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen (perscription or nonperscription). If you are not sure wether a drug contains acetaminophen, ask a doctor or pharmacist.
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, 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 prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• take more or for a longer time than directed
• have 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, iritability, sleeplessness, and occasionally rapid heart beat.

Do not use

• if you are allergic to aspirin or any other pain reliever / fever reducer
• with 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
• if you have ever had an allergic reaction to any other pain reliever-fever reducer
• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

Ask a doctor before using if:

• you have liver disease
• the stomach bleeding warning applies to you
• you have a history of stomach problems (such as heartburn, upset stomach or stomach pain) 
• you have high blood pressure, heart, liver or kidney disease
• you have asthma
• you are taking a diuretic

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.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

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: consult 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*

*contains one or more of these ingredients

Questions or comments?

1-844-428-2538

SPL UNCLASSIFIED SECTION

Manufactured by Ultratab Laboratories, Inc

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

PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Package

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-0752
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	250 mg
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E)	Aspirin	250 mg
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E)	Caffeine	65 mg

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-0752-6	3 in 1 PACKAGE	01/31/2013
1		2 in 1 POUCH; 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	01/31/2013

Labeler - Mechanical Servants LLC (005530951)