Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet
- NDC Code(s): 72090-026-02
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 17, 2021
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- Active Ingredient
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:
- skin reddening
- facial swelling
- asthma (wheezing)
- shock if a skin or general allergic reaction ocurs, stop use and seek medical help right away.
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.
if you have ever had an allergic reaction to this product or any of its ingredients
- Ask Doctor:
- ASK DOCTOR/PHARMACIST:
WHEN USING THIS PRODUCT
you may get drowsy
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
limit the use of caffeine-containing medications, foods, or beverages 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.
KEEP OUT OF REACH OF CHILDREN
Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- STOP USE AND ASK A DOCTOR IF
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
acetaminophen, caffeine, pyrilamine maleate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-026 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength TRIACETIN (UNII: XHX3C3X673) MAGNESIUM STEARATE (UNII: 70097M6I30) SHELLAC (UNII: 46N107B71O) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CARNAUBA WAX (UNII: R12CBM0EIZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color white Score no score Shape CAPSULE Size 27mm Flavor Imprint Code CH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-026-02 40 in 1 BOTTLE; Type 0: Not a Combination Product 07/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/17/2020 Labeler - Pioneer Life Sciences, LLC (014092742)