Topcare Headache PM Formula

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Topco Associates LLC
NDC Code: 36800-355

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Topco Associates LLC. Headache PM Formula Drug Facts

Active ingredients (in each tablet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

(equiv. to Diphenhydramine citrate 38 mg)

Purposes

Pain reliever

Nighttime sleep-aid

Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

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

When using this product
drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not use more than directed (see Liver warning)

adults and children 12 years of age and over:

take 2 tablets at bedtime, if needed, or as directed by a doctor
do not take more than 2 tablets of this product in 24 hours

children under 12 years of age:

do not use

Other information
store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

NON-HABIT FORMING

Headache PM Formula

ACETAMINOPHEN

DIPHENHYDRAMINE HCl

Aspirin Free - Pain Reliever / Nighttime Sleep Aid

actual size

COMPARE TO EXCEDRIN® PM active ingredients

TOPCARE HEADACHE PM FORMULA 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-355
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUND (shallow convex) Size11mm
FlavorImprint CodeL355;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-355-711 BOTTLE in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/25/1997
Labeler - Topco Associates LLC (006935977)

Revised: 01/2013
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)