EXCEDRIN MENSTRUAL COMPLETE
caffeine capsule, gelatin coated Excedrin® MENSTRUAL COMPLETE
Novartis Consumer Health, Inc.
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Releiver/Diuretic Express Gels™
Active ingredients(in each gelcap)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
• temporarily relieves minor aches and pains due to:
• muscular aches • headache • backache • premenstrual & menstrual cramps
• temporarily relieves these symptoms associated with menstrual periods:
• water-weight gain • bloating • swelling • full feeling • fatigue
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 gelcaps 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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
• hives • facial swelling • asthma (wheezing) • shock
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 Doctor or Pharmacist
Ask a doctor or pharmacist before use if you are taking:
- 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 a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- 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
Pregnancy or Breast Feeding
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.
Keep Out of Reach of Children
Keep out of reach of children.
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.
- do not use more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 gelcaps every 4-6 hours; not more than 8 gelcaps in 24 hours
- children under 12 years: ask a doctor
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using. Keep this box for important information.
benzoic acid, D&C red # 28, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
Questions or comments?1-800-468-7746
Distr. By: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622 ©2009
Visit us at www.excedrin.com
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acetaminophen, asprin (nsaid) and caffine
capsule, gelatin coated
||HUMAN OTC DRUG
||NDC Product Code (Source)
|Route of Administration
|Active Ingredient/Active Moiety|
||Basis of Strength
|D&C RED NO. 28
|D&C YELLOW NO. 10
|FD&C GREEN NO. 3
|LIGHT MINERAL OIL
||GREEN (Dark Green)
||CAPSULE (gelatine coated with white ring in middle)
||contains a BOTTLE
||This package is contained within the CARTON (0067-6341-20)
||contains a BOTTLE
||This package is contained within the CARTON (0067-6341-40)
||Application Number or Monograph Citation
||Marketing Start Date
||Marketing End Date
|OTC monograph final
Revised: 10/2009Novartis Consumer Health, Inc.
|Labeler - Novartis Consumer Health, Inc.