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Daytime and Nighttime Pain Relief

Medically reviewed on April 2, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 500mg in 15mL; ACETAMINOPHEN 500mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 15mL
Labeler: CVS Pharmacy, Inc.
NDC Code: 69842-002

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.

Drug Facts - Day Time

Active ingredient (in each 15 mL)

Acetaminophen USP 500 mg

Drug Facts - Night Time

Active ingredients (in each 15 mL)

Acetaminophen USP 500 mg

Diphenhydramine HCl USP 25 mg

Purpose - Day Time

Pain reliever/Fever reducer

Purpose - Night Time

Pain reliever
Nighttime Sleep Aid

Uses - Day Time
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Uses - Night Time

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings - Day Time

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses (120 mL) in 24 hours, which is the maximum daily amount
  • 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.

Warnings - Night Time

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 - Day Time
  • with any other drug containing acetaminophen (prescription or non-prescription). 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

Do not use - Night Time
  • 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 - Day Time

liver disease

Ask a doctor before use if you have - Night Time
  • 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 - Day Time

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Night Time
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers or any other sleep aid

When using this product - Night Time
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if - Day Time
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Stop use and ask a doctor if - Night Time
  • 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 this and all drugs out of the reach of children. - Day Time

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children. - Night Time

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 - Day Time
  • 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; Tbsp= Tablespoon
  • adults and children 12 years and over: take 30 mL (2 Tbsp) in dose cup provided every 4 to 6 hours while symptoms last. Do not take more than 120 mL (8 Tbsp) in 24 hours. Do not take more than 10 days unless directed by a doctor.
  • 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.

Directions - Night Time
  • 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; Tbsp= Tablespoon
  • adults and children 12 years and over: take 30 mL (2 Tbsp) at bedtime. Do not take more than 30 mL (2 Tbsp) in 24 hours.
  • children under 12 years: do not use

Other information - Day Time
  • each 15 mL (1 Tbsp) contains: sodium 7 mg
  • store at 20-25° C (68-77° F).
  • dosage cup provided

Other information - Night Time
  • each 15 mL (1 Tbsp) contains: sodium 9 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients - Day Time

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red 33, FD&C red 40,flavors, high fructose corn syrup, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sucralose.

Inactive ingredients - Night Time

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS MISSING OR BROKEN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-31869

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)

CVS

HealthTM

Compare to the active ingredients in Tylenol®

Extra Strength Adult Rapid Blast Cherry*


NDC 69842-002-35

EXTRA STRENGTH

Daytime
Pain Relief
ACETAMINOPHEN 500 mg
Pain reliever; Fever reducer
Non-drowsy

Cherry Flavor
Rapid Burst

Nighttime
Pain Relief
ACETAMINOPHEN 500 mg
Pain reliever
DIPHENHYDRAMINE HCl 25 mg
Nighttime sleep aid
Alcohol free

Berry Flavor

TWO 8 FL OZ (237 mL) BOTTLES
TOTAL - 16 FL OZ (474 mL)

See Warnings Information

DAYTIME AND NIGHTTIME PAIN RELIEF 
acetaminophen, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-002
Packaging
#Item CodePackage Description
1NDC:69842-002-351 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 237 mL
Part 21 BOTTLE 237 mL
Part 1 of 2
DAYTIME PAIN RELIEF 
pain reliever/fever reducer liquid
Product Information
Item Code (Source)NDC:69842-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
D&C RED NO. 33 
FD&C RED NO. 40 
CHERRY 
MENTHOL 
HIGH FRUCTOSE CORN SYRUP 
SORBITOL 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-003-201 BOTTLE in 1 CARTON
1237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/09/2015
Part 2 of 2
NIGHTTIME PAIN RELIEF 
pain reliever/nighttime sleep aid liquid
Product Information
Item Code (Source)NDC:69842-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C GREEN NO. 3 
BERRY 
PEPPERMINT 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
SORBITOL 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SUCRALOSE 
Product Characteristics
ColorBLUE (blue to bluish green) Score    
ShapeSize
FlavorBERRY, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-004-201 BOTTLE in 1 CARTON
1237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/09/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/09/2015
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(69842-002)

 
CVS Pharmacy, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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