PAIN RELIEF ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hcl tablet, film coated 
Rite Aid Corporation

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Rite Aid 44-235

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime 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

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

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

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
  • drowsiness will occur
  • 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 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 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

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 11822-2350-5

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

EXTRA STRENGTH PAIN RELIEF
ACETAMINOPHEN PM

ACETAMINOPHEN 500 mg • DIPHENHYDRAMINE HCl 25 mg

PAIN RELIEVER/NIGHTTIME SLEEP AID
non-habit forming

ACTUAL SIZE

50 CAPLETS

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

*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark Extra
Strength Tylenol® PM.
50844        REV0521F23515

DISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied, we'll happily refund your money.

Rite Aid 44-235

Rite Aid 44-235

PAIN RELIEF ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2350
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;235
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2350-81 in 1 CARTON04/03/2023
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:11822-2350-51 in 1 CARTON05/15/1994
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:11822-2350-21 in 1 CARTON05/15/1994
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:11822-2350-91 in 1 CARTON03/16/2023
4150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:11822-2350-7300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/1994
6NDC:11822-2350-41 in 1 CARTON05/15/199410/16/2021
62 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/15/1994
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(11822-2350)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(11822-2350) , pack(11822-2350)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(11822-2350)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(11822-2350)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(11822-2350)

Revised: 7/2023
Document Id: 8176ddd9-539d-4197-a5da-9c8d75c8173a
Set id: 17d27771-a112-474f-9a58-29af0d7e1af3
Version: 25
Effective Time: 20230731
 
Rite Aid Corporation