Label: ACETAMINOPHEN, ASPIRIN, CAFFEINE tablet, film coated
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- NDC Code(s): 0536-1326-01
- Packager: Rugby Laboratories
- 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 June 3, 2021
If you are a consumer or patient please visit this version.
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- Drug Facts
- 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 ■ facial swelling ■ shock ■ asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
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: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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
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 have high blood pressure, heart disease, liver cirrhosis, 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 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.
■ 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
■ any new symptoms appear.
These could be signs of a serious condition.
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SPL UNCLASSIFIED SECTION
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
Distributed by: RUGBY® LABORATORIES, Livonia, MI 48152
www.rugbylaboratories.com†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, ASPIRIN, CAFFEINE
acetaminophen, aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1326 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength POLYDEXTROSE (UNII: VH2XOU12IE) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSES (UNII: 3NXW29V3WO) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code 2793 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1326-01 1 in 1 CARTON 06/03/2021 1 100 in 1 BOTTLE; 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 06/03/2021 Labeler - Rugby Laboratories (079246066)
