ACETAMINOPHEN, DIPHENHYDRAMINE HCL- acetaminophen, diphenhydramine hcl tablet, film coated 
CVS Pharmacy, Inc.

----------

0752-CVS

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever and Nighttime sleep-aid

Uses

temporary relief of 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

  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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
  • 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

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • drowsiness will occur

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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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.

In case of accidental overdose, get medical help or contact a 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

Other information

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

1-800-231-4670

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

CVSHealth

Compare to the active ingredients in Extra Strength Tylenol® PM*

EXTRA STRENGTH

Acetaminophen PM

ACETAMINOPHEN, 500 mg

DIPHENHYDRAMINE HCl, 25 mg

Pain reliever/Nighttime sleep aid

Package Contains One Bottle

100 CAPLETS

CVS Label

ACETAMINOPHEN, DIPHENHYDRAMINE HCL 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-572
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
TRIACETIN (UNII: XHX3C3X673)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint Code CPC752
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-572-081 in 1 CARTON07/23/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-572-151 in 1 CARTON07/23/201806/30/2021
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69842-572-121 in 1 CARTON07/23/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69842-572-29150 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2018
5NDC:69842-572-021 in 1 CARTON02/02/2023
5225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/23/2018
Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 1/2024
Document Id: 102f2b61-1316-2afc-e063-6294a90a3553
Set id: 6df9a638-09dd-166f-e053-2991aa0a8dd0
Version: 4
Effective Time: 20240130
 
CVS Pharmacy, Inc.