dg health headache relief description, usages, side effects, indications, overdosage, supplying and lots more!

dg health headache relief

Dolgencorp, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Dolgencorp, LLC Headache Relief PM Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

(equiv. to Diphenhydramine citrate 38 mg)

Purpose

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 the blood thinning drug warfarin
  • •taking sedatives or tranquilizers

When using this product

  • •avoid alcoholic drinks
  • •drowsiness may occur
  • •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?

1-888-309-9030

Principal Display Panel

Compare to active ingredients of Excedrin® PM

Headache Relief PM

Acetaminophen - Diphenhydramine HCl

Pain Reliever/Nighttime Sleep Aid - Aspirin Free

dg health headache relief

Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-355
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 11 mm L355;PM ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:55910-355-71 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-02-14


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Be sure to consult your doctor before taking any medication!
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