Midol Teen

Manufacturer
Bayer HealthCare LLC
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:19:52

Label at a glance#

ProductMidol Teen
Active ingredientACETAMINOPHEN, PAMABROM
Label structure15 sections

Indications and uses

Uses for the temporary relief of these symptoms associated with menstrual periods: · cramps · bloating · water-weight gain · headache · backache · muscle aches

Dosage and administration

· do not take more than the recommended dose · adults and children 12 years and older: · take 2 caplets with water · repeat every 6 hours, as needed · do not exceed 6 caplets per day · children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Pamabrom 25 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 500 mg..............................…………………...Pain reliever

Pamabrom 25 mg……….………………………………………….…..Diuretic

Uses

INDICATIONS & USAGE SECTION

Uses for the temporary relief of these symptoms associated with menstrual periods:
· cramps · bloating · water-weight gain
· headache · backache · muscle aches

Warnings

WARNINGS SECTION

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

· hives · facial swelling · asthma (wheezing)

· shock

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

Do not use

OTC - DO NOT USE SECTION

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 you have ever had an allergic reaction to this product or any of its
ingredients

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

· new symptoms occur

· redness or swelling is present

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

DOSAGE & ADMINISTRATION SECTION

· do not take more than the recommended dose

· adults and children 12 years and older:

· take 2 caplets with water
· repeat every 6 hours, as needed
· do not exceed 6 caplets per day

· children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

Other informationstore at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, croscarmellose sodium, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol TeenMidol Teen

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-8030-24EA - Each0280-8030c18ef67d-3c0f-43ac-95ef-d440b766ba7012016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
PAMABROMACTIVE INGREDIENTUA8U0KJM721
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
BROMOTHEOPHYLLINEACTIVE MOIETYFZG87K1MQ61
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-80300280-8030-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PAMABROMUA8U0KJM72ACTIB
CARNAUBA WAXR12CBM0EIZIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, EXTENDED RELEASE / ORAL2150 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE, EXTENDED RELEASE / ORAL288 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, DELAYED RELEASE / ORAL230 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e3873745-9bfa-7cd4-e053-2995a90a98920733f148-0744-4bb3-e054-00144ff8d46c2022-07-11WarningsExact identifier
spl set id: 0733f148-0744-4bb3-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.