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

Dolex Fem by

Drug Labeling and Warnings

Dolex Fem by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• cramps
• bloating
• water- weight gain
• headache
• backache
• Muscle aches
• fatigue

Warnings

Liver warning: 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.

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

• skin reddening
• blisters
• rash

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

• do not exceed recommended dose
• take every 6 hours. Do not exceed 6 caplets in a 24-hour period
  • adults and children 12 years of age and over: take two (2) tablets, every 6 hours
  • children under 12 years of age: do not use

Other information

• Store at room temperature 77-86°F (25-30°C)

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

NDC: 55758-326-02

NDC: 55758-326-50

INGREDIENTS AND APPEARANCE

DOLEX FEM 
acetaminophen, caffeine, pyrilamine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-326
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	HH7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-326-25	1 in 1 CARTON	10/01/2020
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55758-326-50	25 in 1 BOX	04/07/2023
2	NDC: 55758-326-02	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 55758-326-02	2 in 1 PACKET; Type 0: Not a Combination Product	04/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/01/2020

Labeler - Pharmadel LLC (030129680)