ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG- acetaminophen / diphenhydramine tablet 
Reliable 1 Laboratories 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.

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ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG CAPLET

Drug Facts

Acetaminophen 500 mg

Diphenhydramine HCL 25 mg

Pain reliever

Nighttime sleep aid

temporarily relieves occasional headaches 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

Drug Facts continued on back of label

Ask a doctor or 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: Taking more than the recommended dose (overdose) may cause liver damage. Incase of 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 signs or symptoms.

Directions

adults and children 12 years and over:

children under 12 years: do not use

Other information

store at room temperature 15º-30ºC (59º-86ºF)

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

369618013056-Acetaminophen-Diphenhydramine 500-25 mg CapletsNDC 69618-013-05

Acetaminophen 500 mg & Diphenhydramine HCL 25 mg

PAIN RELIEVER

NIGHTTIME SLEEP AID

50 CAPLETS

*Compare to Active Ingredients in Tylenol® PM

ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG 
acetaminophen / diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-013
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVALSize7mm
FlavorImprint Code AP;133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-013-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)

Revised: 1/2016
Document Id: 2a6a0775-b2c6-5385-e054-00144ff88e88
Set id: 26f5fdd4-d841-2e12-e054-00144ff88e88
Version: 3
Effective Time: 20160128
 
Reliable 1 Laboratories LLC