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
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
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
| EXTRA STRENGTH HEADACH RELIEF
acetaminophen, aspirin, and caffeine tablet |
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| Labeler - Mechanical Servants LLC (005530951) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ultra Seal Corporation | 085752004 | manufacture(29485-0751) , repack(29485-0751) | |