FDA Label for Pamprin Multi-symptom Maximum Strength
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pamprin Multi-symptom Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Focus Consumer Healthcare, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Otc - Purpose
Purposes
Pain reliever
Diuretic
Antihistamine
Indications & Usage
Uses for the temporary relief of these symptoms associated with menstrual periods:
• cramps
• headache
• bloating
• backache
• water-weight gain
• muscular aches
• irritability
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
Otc - Do Not 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.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers
Otc - When Using
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
Otc - Stop Use
Stop use and ask a 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Directions
adults and children 12 years and over:
• take 2 caplets with water every 6 hours as needed
• do not exceed 8 caplets in a 24 hour period or as directed by a doctor
• do not use more than directed (see warnings)
children under 12 years: ask a doctor
Inactive Ingredient
blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
Other
IF IMPRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.
Easy-open bottle with child-resisitant packaging. Purchase only if carton end flaps are sealed.
Distributed by:
Focus Consumer Healthcare, LLC
801 Broad Street, Chattanooga, TN 37402
Made in Canada
©2017 Focus Consumer Healthcare, LLC
www.pamprin.com
Package Label.Principal Display Panel
Maximum Strength
Pamprin Multi-Symptom
for complete Relief of • Cramps •Headache •Backache •Irritability •Bloating
Mentrual Pain Relief
Aspirin-free and Caffeine-free with Acetaminophen, Pamabrom and Pyrilamine Maleate
20 Caplets
* Please review the disclaimer below.