PANADOL Womens Extra Strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, PAMABROM 25mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0434

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 Facts

Active ingredients

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Purpose

Pain reliever

Diuretic

Uses
  • temporarily relieves minor aches and pains due to:
    • menstrual cramps
    • headache
    • backache
  • temporarily relieves water-weight gain, bloating, swelling, and full feeling associated with the premenstrual and menstrual periods

Warnings

Liver warning: This product contains acetaminophen. Sever 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 product 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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms appear

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Overdose warning:

Taking more than the recommended dose can cause serious health problems. 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
  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 8 caplets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other information
  • store below 30°C (86°F)
  • read and retain carton for complete information

Inactive ingredients

croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, triacetin

Questions or comments?

1-800-981-3511 (English/Spanish) weekdays

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 U.S.A.

Made in Panama

©2010 GlaxoSmithKline

Package/Label Principal Display Panel

Women's

EXTRA STRENGTH

PANADOL®

Menstrual Relief

MULTI-SYMPTOM

Acetaminophen - Pain Reliever

Pamabrom - Diuretic

See new warnings information.

24 Caplets

29017XC

PANADOL  WOMENS EXTRA STRENGTH
acetaminophen and pamabrom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0434
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PAMABROM (PAMABROM) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code PAME
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0434-0224 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/13/201103/31/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2011
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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