PAIN AWAY PLUS SLEEP AID - acetaminophen, diphenhydramine hydrochloride liquid 
7-Eleven

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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Drug Facts

Active ingredients

(in each 15 mL)

Acetaminophen USP 500 mg
Diphenhydramine HCl USP 25 mg

Purposes

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

  • 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 reactions. 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • for 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 or any other sleep aid

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 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. (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.

Directions

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter

adults and children 12 years and over
  • take 30 mL at bedtime
  • do not take more than 30 mL in 24 hours
children under 12 years
do not use

Other information

  • each 15 mL contains: sodium 9 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • don't use if shrink band is missing or broken
  • see back label for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C Blue no.1, FD&C Green no. 3, flavors, high fructose corn syrup, menthol, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, and sucralose

Questions or Comments?

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

 

DISTRIBUTED BY

7-ELEVEN, INC.

IRVING, TX 75063

WWW.7-ELEVEN.COM

  

Satisfaction Guaranteed
1-800-255-0711

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

24/7 life
BY 7-ELEVENTM

See Warnings Information
 Pain Away + Sleep aid

Acetaminophen, Diphenhydramine HCl
Pain Reliever, Nighttime Sleep Aid

Do not use if printed shrinkband is missing or broken. 
8 FL OZ (237 mL)                Berry
                                      (Alcohol free)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)



PAIN AWAY PLUS SLEEP AID 
acetaminophen, diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-946
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorBLUE (blue to bluish green) Score    
ShapeSize
FlavorBERRY, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10202-946-201 in 1 CARTON12/01/201707/01/2022
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/01/201707/01/2022
Labeler - 7-Eleven (007347602)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(10202-946)

Revised: 12/2020
 
7-Eleven