Menstrual Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Menstrual Relief

Safeway

Safeway 44-391




FULL PRESCRIBING INFORMATION

(in each gelcap)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Pain reliever

Stimulant

Diuretic

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backahe
  • breast tenderness
  • fatigue
  • 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
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • difficulty in urination due to enlargmement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • blaucoma
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • 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.
  • 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.

Ask a health professional before use.

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
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

black iron oxide, cellulose, crocarmellose sodium, FD&C blue #1, gelatin, hypromellose, magnesium stearate, polyethylene glycol, povidone, silica gel, starch, stearic acid, titanium dioxide

1-800-426-9391

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 21130-391-08

Compare

to Midol®

active ingredients*

Maximum Strength

Menstrual Relief

Acetaminophen, 500 mg

Caffeine, 60 mg

Pyrilamine maleate, 15 mg

Pain Reliever / Stimulant / Diuretic

Maximum Strength Relief Of:

• Cramps • Bloating • Fatigue

•Backache • Headache

ACTUAL SIZE

SEE NEW WARNING INFORMATION

24 GELCAPS

SAFEWAY™

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844     REV0310B39108

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA 94566-0009

QUALITY & SATISFACTION GUARANTEED

OR YOUR MONEY BACK

1-888-SAFEWAY / www.safeway.com

Menstrual Relief
Product Packaging

Menstrual Relief

Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-391
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 60 mg
PYRILAMINE MALEATE PYRILAMINE 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 Size Imprint Code Shape
BLUE 21 mm 44;391 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:21130-391-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2001-06-14


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Be sure to consult your doctor before taking any medication!
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