DOLEX FEM- acetaminophen, caffeine, pyrilamine maleate tablet, coated 
Pharmadel LLC

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.

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Dolex Fem (Health Pharma)

Drug Facts

Active ingredients & Purposes

Active ingredients (in each caplet)Purposes
Acetaminophen 500mg............................Pain reliever
Caffeing 60mg .........................................Diuretic
Pyrilamine maleate 15mg.........................Anthistamine

Uses

For the temporary relief of these symptoms associated with menstrual periods

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 heart beat.

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.
  • for more than 10 days for pain unless directed by a doctor
  • if allergic to any of the ingredients in this product

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

  • may cause excitability in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain persist or gets worse

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k30, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-866-359-3478 (M-F) 9AM - 5PM or www.pharmadel.com

*This product is not manufactured or distributed by Bayer Healthcare LLC owner of the registered trademark MidolⓇ Complete.

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Compare to MidolⓇ Complete active ingredients*

Dolex Fem

Menstrual Complete

Acetaminophen, Caffeine, Pyrilamine Maelate

NDC 55758-326-25

PDP 24ct

NDC 55758-326-02

PDP 25x2

NDC 55758-326-50

PDP 25x2 Display

DOLEX FEM 
acetaminophen, caffeine, pyrilamine maleate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-326
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code HH7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-326-251 in 1 CARTON10/01/2020
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:55758-326-5025 in 1 BOX04/07/2023
2NDC:55758-326-022 in 1 PACKET; Type 0: Not a Combination Product
3NDC:55758-326-022 in 1 PACKET; Type 0: Not a Combination Product04/07/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/01/2020
Labeler - Pharmadel LLC (030129680)

Revised: 4/2023
Document Id: f93aa87d-e500-ff38-e053-6294a90ad0d4
Set id: b1cab10b-19f1-f5d5-e053-2995a90a4d5f
Version: 8
Effective Time: 20230413
 
Pharmadel LLC