ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG- acetaminophen 500mg diphenhydramine hcl 25mg tablet 
Strive Pharmaceuticals Inc

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.

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Pain Relief PM - Extra Strength
Body Pain - Dolor Corporal
(Acetaminophen 500mg; Diphenhydramine Hydrochloride 25mg)

Acetaminophen 500mg; Diphenhydramine 25mg

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

adults and children 12 years of age and over
  • 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
children under 12 years of agedo not use

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

if a skin reaction occurs, stop use and seek medical help right away

Do not use

Ask a doctor before use if you have

Ask a doctor or a pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Pain reliever

Nighttime sleep-aid

LB11905CT11905CT11941

ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG 
acetaminophen 500mg diphenhydramine hcl 25mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (LIGHT BLUE) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code AD01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-119-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
2NDC:70692-119-0550 in 1 PACKAGE; Type 0: Not a Combination Product09/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/20/2018
Labeler - Strive Pharmaceuticals Inc (080028013)

Revised: 11/2020
Document Id: b43d776e-b5f4-16b9-e053-2995a90a66b9
Set id: 9238598b-1202-921f-e053-2995a90a019f
Version: 3
Effective Time: 20201116
 
Strive Pharmaceuticals Inc