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healthy mama eaZZZe THE PAIN

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: MATERNAL SCIENCE, LLC
NDC Code: 58154-104

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.

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25mg


Purposes

Pain RelieverNighttime Sleep Aid


Uses

Temporary relief of occasional headaches and minor aches with 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 everyday while using this product

When using this prodcut
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Keep out of reach of children.

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 a doctor before use if you are
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

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

Stop use and ask a doctor if
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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. These could be signs of a serious condition.

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

Overdose warning

Taking more than the recommended dose(overdose) may cause liver damage. 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 take more than directed(see overdose warning)

               Adults and children 12 years and over: Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours

               

               Children under 12 years: Do not use this adult product in children under 12 years of age: this will provide more than the     

               recommended dose(overdose) and may cause liver damage.    


Other information
  • Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments. or to report  an adverse event, please contact (xxx) xxx-xxxx.


Principal Display Panel

healthy

mama

eaZZZe THE PAIN!

acetaminophen 500mg diphenhydramine HCl 25 mg

PAIN RELIEVER AND NIGHTTIME AID

extra strength aspirin free


40 caplets

HEALTHY MAMA  EAZZZE THE PAIN
acetaminophen diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58154-104
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
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule shaped tablet) Size18mm
FlavorImprint CodeGP325
Contains    
Packaging
#Item CodePackage Description
1NDC:58154-104-0140 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/29/2013
Labeler - MATERNAL SCIENCE, LLC (078722406)

 
MATERNAL SCIENCE, LLC

Medically reviewed on Apr 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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