ACETAMINOPHEN DIPHENHYDRAMINE HCL- acetaminophen diphenhydramine hcl tablet 
BETTER LIVING BRANDS LLC.

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Extra Strength
Pain Releif PM

Acetaminophen USP, 500mg
Diphenhydramine HCL USP, 25mg

Pain Reliever/Nighttime Sleep-Aid
RAPID RELEASE

Active ingredient

Acetaminophen, USP 500 mg

Diphenhydramine HCl, USP 25 mg

Purpose

Pain reliever

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:
■ 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

Allergy alert

acetaminophen may cause severe skin reaction. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away

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
■ 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
■ 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

■ drowsiness will occur
■ avoid alcoholic drinks
■ 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 serious underlying medical illness.
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of the reach of children

Overdose warning


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

do not take more than directed (see overdose warning)


adults and children 12 years and over
■ take 2 gelcaps at bedtime
■ do not take more than 2 gelcaps of this product in 24 hours
children under 12 years
do not use

Other information

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for lot number and expiration date

Inactive Ingrdients

colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin

Questions or Comments?

call 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

20ct08

ACETAMINOPHEN DIPHENHYDRAMINE HCL 
acetaminophen diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-354
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
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIACETIN (UNII: XHX3C3X673)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POVIDONE K30 (UNII: U725QWY32X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorgray ((Encapsulated gray color tablets with dark blue opaque and light blue opaque hard gelatin shells)) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code G3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-354-0220 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2022
2NDC:21130-354-0880 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/12/2022
Labeler - BETTER LIVING BRANDS LLC. (009137209)

Revised: 12/2023
Document Id: 0ccdc7b3-14f8-7d15-e063-6394a90a503b
Set id: ac0f8d5c-d200-1156-e053-2a95a90aece6
Version: 3
Effective Time: 20231218
 
BETTER LIVING BRANDS LLC.