Label: HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated
- NDC Code(s): 49035-334-06, 49035-334-08, 49035-334-12, 49035-334-42
- Packager: Wal-Mart Stores Inc
- 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 July 20, 2019
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- Active ingredients (in each caplet)
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: Aspirin may cause a severe allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
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
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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]
- 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 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 are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
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 bloody 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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
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.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
†Compare to the active ingredients in Excedrin® Extra Strength Caplets
Acetaminophen, Aspirin (NSAID)
and Caffeine Caplets
Pain Reliever/Pain Reliever Aid
24 COATED CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength Caplets.
Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
INGREDIENTS AND APPEARANCE
HEADACHE RELIEF EXTRA STRENGTH
acetaminophen, aspirin and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-334 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 HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE (UNII: 2S7830E561) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;334 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-334-06 2 in 1 CARTON 03/13/2008 09/11/2020 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-334-08 1 in 1 CARTON 03/13/2008 09/11/2020 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49035-334-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/13/2008 09/11/2020 4 NDC:49035-334-42 200 in 1 BOTTLE; Type 0: Not a Combination Product 03/13/2008 09/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 03/13/2008 09/11/2020 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(49035-334) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(49035-334) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(49035-334) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(49035-334)