Label: MENSTRUAL PAIN RELIEF COMPLETE- acetaminophen, pyrilamine maleate, caffeine tablet, film coated
- NDC Code(s): 83059-0006-1
- Packager: Shield Pharmaceuticals Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 16, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each liquid-filled capsule)
- Purpose
- Uses
-
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin reaction occurs, stop use and seek medical help right away.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product
- avoid alcoholic beverages
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machiner
- alcohol, sedatives, and tranquilizers may increase drowsiness
- you may get drowsy
- 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
-
Inactive ingredients
aerosil, calcium phosphate, colloidal silicon dioxide, cross carmellose sodium, FD&C yellow #6, hypromellose, isopropyl alcohol, magnesium stearate, methlyene chloride, microcrystalline cellulose, pregelatinized starch, polyethylene glycols, poly vinyl pyrrolidone, povidone, stearic acid, talc, titanium dioxide
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MENSTRUAL PAIN RELIEF COMPLETE
acetaminophen, pyrilamine maleate, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83059-0006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLENE CHLORIDE (UNII: 588X2YUY0A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PYRROLIDONE (UNII: KKL5D39EOL) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code S17;M7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83059-0006-1 1 in 1 CARTON 01/16/2024 1 15 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/16/2024 Labeler - Shield Pharmaceuticals Corp (118724924)