Label: EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet
- NDC Code(s): 29485-0752-6
- Packager: Mechanical Servants LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 25, 2019
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- ACTIVE INGREDIENT
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.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
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)
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.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- 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)