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.
• 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

• excitability may occur, especially 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

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days

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
• Do not exceed 6 caplets in a 24- hour period
• adultos and children 12 years of age and over: take two (2) caplets, 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.

Prinicpal Display Panel

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
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
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	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	04/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	10/01/2020

Labeler - Pharmadel LLC (030129680)