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Pain Relief PM Extra Strength by Allegiant Health

Medically reviewed on November 16, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Allegiant Health
NDC Code: 69168-267

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 ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep aid

Uses

temporarily relieves 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 4000 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 sever skin reactions.
Symptoms may include:    ■ skin reddening   ■ blisters   ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

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
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

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

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

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
  • redness or swelling is present
  • new symptoms occur. 

These could be signs of a serious condition.

  • You may report side effects to 1-888-952-0050

If pregnant 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt 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

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Package/Label Principal Display Panel

Health A2Z®                  Compare to Tylenol® PM active ingredient*

See New Warnings Information

Extra Strength

Pain Reliever/Sleep Aid

PAIN RELIEF PM  
Acetaminophen 500mg   
Diphenhydramine HCl 25mg

Caplets

Pain Relief PM 24ct. Caplets

Pain Relief PM 24ct. Caplets

PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-267
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 
FD&C BLUE NO. 1 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeAZ267
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-267-02150 TABLET in 1 BOTTLE
2NDC:69168-267-2424 TABLET in 1 CARTON
3NDC:69168-267-5050 TABLET in 1 CARTON
4NDC:69168-267-99365 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/23/2014
Labeler - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-267), LABEL(69168-267), MANUFACTURE(69168-267), PACK(69168-267)

 
Allegiant Health

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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.

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