ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen and diphenhydramine hydrochloride tablet 
Better Living Brands, LLC

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Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 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

Ask a doctor before use if you have

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.

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

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions or comments?

1-855-274-4122

DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99, PLEASANTON,
CA 94566-0009,
1-888-723-3929

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle)

NDC 21130-224-73

Signature
care ®
Quality
Guaranteed

Extra Strength
Pain Relief PM

ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE
HYDROCHLORIDE 25 mg
GELCAPS

Pain Reliever/Nighttime Sleep Aid

Non-habit forming

RAPID RELEASE

20 GELCAPS


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle Carton)

Signature
care
®
Quality
Guaranteed

Compare to
Extra Strength
TYLENOL ®PM
active ingredient *

NDC 21130-224-73

Extra Strength
Pain Relief PM

ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE
HYDROCHLORIDE 25 mg
GELCAPS

Pain Reliever/Nighttime Sleep Aid

Non-habit forming

RAPID RELEASE

Actual Size

20 GELCAPS



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle Carton)
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-224
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
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Dark blue and Light blue with white band) Scoreno score
ShapeCAPSULE (Biconvex) Size20mm
FlavorImprint Code T;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-224-731 in 1 CARTON11/18/2023
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-224-181 in 1 CARTON11/18/2023
280 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/18/2023
Labeler - Better Living Brands, LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777analysis(21130-224) , manufacture(21130-224)

Revised: 11/2023
Document Id: 0b35e6d7-d8ed-de5d-e063-6394a90a1777
Set id: fc07d516-9ffe-9989-e053-6294a90ae1a5
Version: 2
Effective Time: 20231128
 
Better Living Brands, LLC