Label: EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin and caffeine tablet
- NDC Code(s): 41163-159-08, 41163-159-12
- Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drugClose
Pain reliever aid
- temporarily relieves minor aches and pains due to:
- a cold
- muscular aches
- premenstrual and menstrual cramps
- temporarily relieves minor aches and pains due to:
Reye's syndrome: Children and teenagers who have or are reovering 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: Aspirin may cause a severe allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
Liver warning: This product contains acetaminophen. Sever 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
- 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:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [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, occasionally, rapid heartbeat.
Do not use
- if you ever had an allergic reaction to 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
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have liver idease
- you have high blood pressure, heart disease, liver disease or kidney disease
- you have asthma
- you are taking a diuertic
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor's care for any serious condition
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloddy or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- painful area is red or swollen
- fever gets worse or lasts more than 3 days
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 beause 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 eveni f you do not notice any signs or symptoms.
- do not use more than directed
- drink a full a full glass of water with each dose
- adults and children 12 years and over
- take 2 tablets every 6 hours
- do not take more than 8 tablets in 24 hours
- children under 12 years: do not use unless directed by a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal display panel
compare to Extra Strength Excedrin® active ingredients**
acetaminophen, aspirin (NSAID)
pain reliever/pain reliever aid
24 coated tablets
DOES NOT CONTAIN GLUTEN
**This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRARITE, MN 55344 USA
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- INGREDIENTS AND APPEARANCE
EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin, caffeine tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-159 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg ASPIRIN (ASPIRIN) ASPIRIN 250 mg CAFFEINE (CAFFEINE) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN TALC SODIUM LAURYL SULFATE Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code 44;159 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-159-08 1 in 1 CARTON 1 24 in 1 BAG 2 NDC:41163-159-12 1 in 1 CARTON 2 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 11/17/1992 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41163-159) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(41163-159)