NDC | 53808-0834-1 |
Set ID | 081ca362-bfd1-4eeb-b2a1-b47f05ee0e2f |
Category | HUMAN OTC DRUG LABEL |
Packager | State of Florida DOH Central Pharmacy |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Close - Purpose
- Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual & menstrual cramps
- temporarily relieves minor aches and pains due to:
- 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
- asthma (wheezing)
- shock
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tables 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 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 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
- high blood pressure
- you have asthma
Ask a doctor or pharmacist before use
- any other drug containing an NSAID (prescription or nonprescription)
- a blood thinning (anticoagulant) or steroid drug
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs os stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
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.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- do not use more than directed (see Overdose Warning)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tables in 24 hours
- children under 12 years: ask a doctor
Other information
- store at controlled room temperature 200 - 250 C (680 - 770 F)
- read all product information before using. Keep this box for important information
- Inactive ingredients
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
Close - Questions or comments
1-800-468-7746
This product is supplied by State of Florida DOH Central Pharmacy as follows:
NDC Strength Quantity/Form Color Source Prod. Code 53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030 This product was Manufactured By:
Novartis Pharmaceuticals Corporation
One Health PlazaAnd Repackaged By:
State of Florida DOH Central Pharmacy
Close
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States - Principal Display Panel
- INGREDIENTS AND APPEARANCE
EXCEDRIN EXTRA STRENGTH
acetaminophen, aspirin (nsaid), and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0834(NDC:0067-2030) 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIMETHICONE 410 (UNII: TYU5GP6XGE) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White) Score no score Shape ROUND Size 11mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0834-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 01/01/2013 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0834)