Label: EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE- acetaminophen, salicyclic acid, caffeine tablet, film coated
- NDC Code(s): 53329-988-30
- Packager: Medline Industries
- 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 June 4, 2020
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- Active ingredient (in each tablet)
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)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If 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 8 tablets 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 which 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.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask doctor before use if
- 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
- you have liver disease
Stop using and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- painful area is red or swollen
- symptoms do not improve
- any new symptoms appear
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
- fever gets worse or lasts for more than 3 days
- pain gets worse or lasts for more than 10 days
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
SPL UNCLASSIFIED SECTION
www.medline.com Manufactured in the USA with US and foreign components by:
Medline Industries, Inc.,
Three Lakes Drive, Northfield, IL 60093 USA
†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Extra Strength.
- Package Label
INGREDIENTS AND APPEARANCE
EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE
acetaminophen, salicyclic acid, caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-988 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score score with uneven pieces Shape CAPSULE (capsule shaped tablet) Size 18mm Flavor Imprint Code TCL370 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-988-30 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/04/2018 Labeler - Medline Industries (025460908) Establishment Name Address ID/FEI Business Operations Time Cap Labs 037052099 manufacture(53329-988) Establishment Name Address ID/FEI Business Operations Medline Industries 079800021 repack(53329-988)