EXTRA STRENGTH NO-PAIN PM- acetaminophen and diphenhydramine hydrochloride tablet 
Safrel Pharmaceuticals, LLC.

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.

----------

Pain Relief PM - Acetaminophen and Diphenhydramine HCl

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid

Uses

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 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 before use 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.

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

Keep out of reach of children.

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

Other information

Inactive ingredients

colloidal silicon dioxide, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake,
magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol,
povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-844-384-3723 (Mon-Fri 9am-5pm EST) or www.safrelpharma.com

PRINCIPAL DISPLAY PANEL


Compare to the Active Ingredients in
Tylenol PM
®*

Pain Relief PM

Pain RelieverNighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

apap pm

EXTRA STRENGTH NO-PAIN PM 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-006-2525 in 1 BOX06/06/2016
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:71309-006-5050 in 1 BOX06/06/2016
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:71309-006-022 in 1 POUCH06/06/2016
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:71309-006-37375 in 1 BOTTLE06/06/2016
4NDC:71309-006-05500 in 1 BOTTLE
4NDC:71309-006-3030 in 1 BOTTLE
41 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/09/2016
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 5/2021
Document Id: c3a3d290-045b-324c-e053-2995a90a3a38
Set id: 87655c3e-acab-bdc2-e053-2a95a90ae2a1
Version: 3
Effective Time: 20210531
 
Safrel Pharmaceuticals, LLC.