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

Extra Strength Headache Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
* nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg	Pain reliever
Aspirin 250 mg (NSAID*)	Pain reliever
Caffeine 65 mg	Pain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual & menstrual cramps

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 skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

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:

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

Liver warning

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

• more than 8 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

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 NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

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 occasional rapid heart beat.

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 liver disease
• stomach bleeding warning 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

Ask a doctor or pharmacist before use if you are taking

• a prescription drug for diabetes, gout, or arthritis
• any other drug, or are under a doctor's care for any serious condition

Stop use and ask a 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 stools
  • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• 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
• any new symptoms occur

These could be signs of a serious condition

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 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.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not use more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at room temperature between 20-25°C (68 to 77°F)
• avoid excessive heat, cold and humidity
• close cap tightly after use
• read all product information before using.

Inactive ingredients

croscarmellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol , polyvinyl alcohol, povidone, purified talc, sodium lauryl sulphate, sodium starch glycolate, starch, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton

Compare to active ingredients
in Excedrine® Extra Strength††

NDC XXXXX-XXX-XX

Headache
Relief

ACETAMINOPHEN /
ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER /
PAIN RELIEVER AID

EXTRA STRENGTH

ACTUAL SIZE

100 CAPLETS

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-440
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
Croscarmellose (UNII: 029TFK992N)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polacrilin Potassium (UNII: 0BZ5A00FQU)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
Talc (UNII: 7SEV7J4R1U)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Starch Glycolate Type A (UNII: H8AV0SQX4D)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	S142
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-440-01	1 in 1 CARTON	05/01/2021
1		100 in 1 BOTTLE; 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	05/01/2021

Labeler - Dollar General (068331990)