Label: HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet, film coated
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- NDC Code(s): 70000-0146-1
- Packager: Cardinal Health
- 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.
Drug Label Information
Updated April 5, 2021
If you are a consumer or patient please visit this version.
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- Active ingredients (in each caplet)
- Purpose
- Uses
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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: Aspirin may cause a severe allergic reaction, which may include:
- hives
- shock
- facial swelling
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- rash
- blisters
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
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
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 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you have liver disease
- you have asthma
- 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
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
- an allergic reaction occurs. Seek medical help right away.
- 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
- ringing in the ears or a loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
LEADER™
NDC 70000-0146-1
Extra Strength
Headache Relief
Acetaminophen | Aspirin (NSAID) | Caffeine
Pain Reliever | Pain Reliever AidCOMPARE TO EXCEDRIN®
EXTRA STRENGTH CAPLETS
active ingredients†100% Money Back Guarantee
24 CAPLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
100% Money Back Guarantee
Return to place of purchase if not satisfied.CIN 5285754 REV. 4/20
†This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Excedrin® Extra Strength Caplets.
50844 REV1119C33408DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313©2020 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.
Leader 44-334B
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INGREDIENTS AND APPEARANCE
HEADACHE RELIEF EXTRA STRENGTH
acetaminophen, aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0146 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 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:70000-0146-1 1 in 1 CARTON 03/13/2008 1 24 in 1 BOTTLE, PLASTIC; 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 03/13/2008 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0146) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0146) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0146) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(70000-0146)