HEADACHE FORMULA PM- acetaminophen and diphenhydramine citrate tablet, film coated 
SUPERVALU 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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Equaline 44-373

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

for the 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 other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age 

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

  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur 

Stop use and ask a doctor if

  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • painful area is red or swollen

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets of this product in 24 hours.
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number  

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-877-932-7948

Principal Display Panel

equaline®

compare to Excedrin® PM
active ingredients*

NDC 41163-373-12

headache formula PM

acetaminophen
and diphenhydramine citrate

aspirin free
pain reliever / nighttime sleep-aid

100 tablets

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

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.
50844     REV0712A37312

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com

Equaline 44-373

Equaline 44-373

HEADACHE FORMULA PM 
acetaminophen and diphenhydramine citrate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-373
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;373
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-373-121 in 1 CARTON06/07/200402/17/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/07/200402/17/2020
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41163-373)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(41163-373)

Revised: 3/2017
 
SUPERVALU INC.