Label: PREMSYN PMS PREMENSTRUAL PAIN RELIEF- acetaminophen and pamabrom and pyrilamine maleate tablet
- NDC Code(s): 71687-3102-4
- Packager: Focus Consumer Healthcare, 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.
Drug Label Information
Updated June 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Allergy Warning: Acetaminophen may cause severe skin reactions.
Symptoms may include:- skin reddening
- blisters
- rash
if a skin reaction occurs stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 caplets 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:
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargment of the prostate gland.
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, avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving or operating machinery
- excitability may occur, especially in children
stop use and ask doctor if:
- Pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- If pregnant or breastfeeding, ask a health professional before use.
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
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
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, avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving or operating machinery
- excitability may occur, especially in children
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREMSYN PMS PREMENSTRUAL PAIN RELIEF
acetaminophen and pamabrom and pyrilamine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71687-3102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color purple (FD & C Red No. 40) Score no score Shape OVAL Size 18mm Flavor Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71687-3102-4 1 in 1 CARTON 10/13/2017 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/13/2017 Labeler - Focus Consumer Healthcare, LLC (080743737)
