Label: MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate capsule, liquid filled
- NDC Code(s): 0363-0391-08
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients
(in each gelcap)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mgClose
for the temporary relief of these symptoms associated with menstrual periods:
- water-weight gain
- breast tenderness
- muscle aches
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
Do not use
- 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
- difficulty in urination due to enlargmement of the prostate gland
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- you may get drowsy
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- 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. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if
- new symptoms appear
- redness or swelling is present
- pain gets worse or lasts more than 10 days
These could be signs of a serious condition.
Keep out of the reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 take more than the recommended dose (see overdose warning)
- adults and children 12 years and older: take 2 gelcaps with water. Repeat every 6 hours, as needed. Do not exceed 8 gelcaps in 24 hours.
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive ingredients
black iron oxide, cellulose, crocarmellose sodium, FD&C blue #1, gelatin, hypromellose, magnesium stearate, polyethylene glycol, povidone, silica gel, starch, stearic acid, titanium dioxideClose
- Questions of comments?
- Product Packaging
Compare to Midol® Complete
Acetaminophen 500 mg,
Caffeine 60 mg,
Pyrilamine maleate 15 mg
Relief of Menstrual Symptoms:
• Cramps • Bloating • Fatigue • Headaches • Backaches
SEE NEW WARNINGS INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by: Walgreen Co.,
200 Wilmot Rd.,
Deerfield, IL 60015-4616
- INGREDIENTS AND APPEARANCE
acetaminophen, caffeine, pyrilamine maleate capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0391 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg CAFFEINE (CAFFEINE) CAFFEINE 60 mg PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE POWDERED CELLULOSE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 GELATIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE Product Characteristics Color BLUE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 44;391 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0391-08 1 in 1 CARTON 1 24 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 06/14/2001 Labeler - WALGREEN CO. (008965063)