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EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin, and caffeine tablet, film coated Lil Drug Store Products, Inc 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.
Excedrin® Extra Strength Drug Facts Active ingredients (in each caplet) Purposes
Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID ) Pain reliever Caffeine 65 mg Pain reliever aid Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps 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 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. Allergy alert nonsteroidal anti-inflammatory drug
Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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 with other drugs containing acetaminophen 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) 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 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 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 are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition
PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton EXCEDRIN ® EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 6 Caplets 3 PACKETS OF 2 CAPLETS Lil' Drug Store
EXCEDRIN EXTRA STRENGTH
acetaminophen, aspirin, and caffeine tablet, film coated Product Information Product Type HUMAN OTC DRUG^ Item Code (Source) NDC:66715- 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 BENZOIC ACID (UNII: 8SKN0B0MIM) CARNAUBA WAX (UNII: R12CBM0EIZ ) ®
Lil Drug Store Products, Inc FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (UNII: FZ 989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z 65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (White)^ Score no s core Shape CAPSULE (Caps ule-Shaped Tablet)^ Size 18mm Flavor Imprint Code E **Contains Packaging
Item Code Package Description Marketing Start
Date Marketing End Date 1** NDC:66715- 9810- 2 in 1 CARTON 02/04/2016 07/15/ 1^2 Product^ in 1 POUCH; Type 0: Not a Combination 2 NDC:66715- 9810-3 3 in 1 CARTON 05/12/ 2^2 Product^ in 1 POUCH; Type 0: Not a Combination
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/10/
Labeler - Lil Drug Store Products, Inc (093103646)
Revised: 7/
