NDC | 69842-002-35, 69842-003-20, 69842-004-20 |
Set ID | b5265dc4-ec50-4257-a2df-2e7dd54c58c8 |
Category | Human OTC Drug Label |
Packager | CVS Pharmacy, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Drug Facts - Day Time
- Drug Facts - Night Time
- Purpose - Day Time
- Purpose - Night Time
- Uses - Day Time
- Uses - Night Time
-
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
-
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
- Ask a doctor before use if you have - Night Time
- Ask a doctor or pharmacist before use if you are - Day Time
- Ask a doctor or pharmacist before use if you are - Night Time
- When using this product - Night Time
- Stop use and ask a doctor if - Day Time
-
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,
-
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
- Other information - Night Time
- Inactive ingredients - Day Time
- Inactive ingredients - Night Time
- Questions or comments?
-
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
-
INGREDIENTS AND APPEARANCE
DAYTIME AND NIGHTTIME PAIN RELIEF
acetaminophen, diphenhydramine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-002-35 1 in 1 CARTON; Type 0: Not a Combination Product 12/09/2015 07/01/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 237 mL Part 2 1 BOTTLE 237 mL Part 1 of 2 DAYTIME PAIN RELIEF
pain reliever/fever reducer liquidProduct Information Item Code (Source) NDC:69842-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) CHERRY (UNII: BUC5I9595W) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor CHERRY, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-003-20 1 in 1 CARTON 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/09/2015 07/01/2022 Part 2 of 2 NIGHTTIME PAIN RELIEF
pain reliever/nighttime sleep aid liquidProduct Information Item Code (Source) NDC:69842-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) PEPPERMINT (UNII: V95R5KMY2B) 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 Color BLUE (blue to bluish green) Score Shape Size Flavor BERRY, PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-004-20 1 in 1 CARTON 1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/09/2015 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/09/2015 07/01/2022 Labeler - CVS Pharmacy, Inc. (062312574) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(69842-002)