dolex fem (hhh)

SPL v13

SPL

SPL Set ID b1cab10b-19f1-f5d5-e053-2995a90a4d5f

Route

oral

Published

Effective Date 2023-04-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

acetaminophen (500 mg) caffeine (60 mg) pyrilamine (15 mg)

Inactive Ingredients

starch, corn silicon dioxide titanium dioxide microcrystalline cellulose polyethylene glycol 400 stearic acid water magnesium stearate hypromellose, unspecified povidone k30 talc

Identifiers & Packaging

Pill Appearance

Imprint: HH7 Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

otc monograph drug active Since 2020-10-01 Until 2023-04-07

Purpose

Description

Medication Information

Warnings

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

more than 6 tablets 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.

Uses

For the temporary relief of these symptoms associated with menstrual periods

cramps
bloating
water- weight gain
headache
backache
Muscle aches
fatigue

Purpose

Directions

Do not exceed recommended dose
adultos and children 12 years of age and over: take two (2) caplets, every 6 hours, do not exceed 6 caplets in a 24- hour period
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 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water

Description

Section 55105-1

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

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

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

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

Active Ingredients & Purposes

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.

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

Structured Label Content

Warnings

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

more than 6 tablets 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.

Uses

For the temporary relief of these symptoms associated with menstrual periods

cramps
bloating
water- weight gain
headache
backache
Muscle aches
fatigue

Directions

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water

Section 55105-1 (55105-1)

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

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.
if allergic to any of the ingredients in this product

Questions Or Comments? (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

When Using This Product (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 (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

Active Ingredients & Purposes (Active ingredients & Purposes)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PYRILAMINE", "unii": "HPE317O9TL", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of these symptoms associated with menstrual periods cramps bloating water- weight gain headache backache Muscle aches fatigue", "55105-1": "Active ingredients (in each tablet) Purposes Acetaminophen 500mg............................ Pain reliever Caffeing 60mg ......................................... Diuretic Pyrilamine maleate 15mg......................... Anthistamine", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets 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.", "Directions": "Do not exceed recommended dose adultos and children 12 years of age and over: take two (2) caplets, every 6 hours, do not exceed 6 caplets in a 24- hour period children under 12 years of age: 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. if allergic to any of the ingredients in this product", "Other information": "Store at room temperature 77-86°F (25-30°C)", "Inactive ingredients": "corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, titanium dioxide, water", "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.", "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", "Active ingredients & Purposes": ".", "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.", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:39.884834 · Updated: 2026-03-14T23:13:42.453292