Midol PM by Bayer HealthCare LLC. / Bayer HealthCare LLC Consumer Care MIDOL PM tablet, coated

Midol PM by

Drug Labeling and Warnings

Midol PM by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet) Purpose

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

Diphenhydramine citrate 38 mg…….…………………..Nighttime sleep-aid

PURPOSE

INDICATIONS & USAGE

Use for relief of occasional sleeplessness when associated with minor aches and pains from premenstrual and menstrual periods (dysmenorrhea).

WARNINGS

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

· more than 4,000 mg of acetaminophen in 24 hours

· 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

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.

· in children under 12 years of age

· with any other product containing diphenhydramine, even one used

on skin

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

ASK DOCTOR

Ask a doctor before use if you have

· liver disease

· a breathing problem such as emphysema or chronic bronchitis

· glaucoma

· difficulty in urination due to enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

· taking the blood thinning drug warfarin

· taking sedatives or tranquilizers

WHEN USING

When using this product

· drowsiness will occur

· avoid alcoholic drinks

· do not drive a motor vehicle or operate machinery

STOP USE

Stop use and ask a doctor if

· sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

· new symptoms occur

· redness or swelling is present

PREGNANCY 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. 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

Directions

· do not take more than the recommended dose

· adults and children 12 years and older: take 2 caplets at bedtime if needed, or as directed by a doctor

· children under 12 years: do not use

OTHER SAFETY INFORMATION

Other information store at room temperature

Inactive ingredients

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, povidone, propylene glycol, shellac, stearic acid, titanium dioxide

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIDOL PM 
midol pm tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-8070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE CITRATE	38 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	MIDOL;PM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-8070-20	1 in 1 CARTON	12/15/2014
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/15/2014

Labeler - Bayer HealthCare LLC. (112117283)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer HealthCare LLC Consumer Care		072827066	manufacture(0280-8070) , pack(0280-8070)