Indications and uses
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
Daytime and Nighttime Pain Relief
- Manufacturer
- CVS Pharmacy, Inc. | Aurohealth LLC
- Effective date
- 2020-12-10
- Label type
- Human OTC Drug Label
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:02:33
Label at a glance#
ProductDaytime and Nighttime Pain Relief
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure28 sections
Dosage and administration
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. ...
Storage and handling
each 15 mL (1 Tbsp) contains: sodium 7 mg store at 20-25° C (68-77° F). dosage cup provided
Contacts and useful links#
Label contents#
Full prescribing information#
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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| BERRY | INACTIVE INGREDIENT | FV3431923Z | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Daytime and Nighttime Pain Relief
- Acetaminophen, Diphenhydramine HCl
- Daytime Pain Relief
- Pain reliever/Fever reducer
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- D&C RED NO. 33
- FD&C RED NO. 40
- CHERRY
- MENTHOL, UNSPECIFIED FORM
- HIGH FRUCTOSE CORN SYRUP
- SORBITOL
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SUCRALOSE
- Nighttime Pain Relief
- Pain reliever/Nighttime sleep aid
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- FD&C GREEN NO. 3
- PEPPERMINT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-002 | 69842-002-35 |
| 69842-003 | 69842-003-20 |
| 69842-004 | 69842-004-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INFILTRATION | 0.02 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / RESPIRATORY (INHALATION) | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CONCENTRATE / ORAL | 0.02 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | MOUTHWASH / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE / ORAL | 1 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION / ORAL | 20000 mg | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION, EXTENDED RELEASE / ORAL | 3000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRALESIONAL | 15 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SUSPENSION / ORAL | 570 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / ORAL | 280 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, EXTENDED RELEASE / ORAL | 933 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED / ORAL | 50 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EFFERVESCENT / ORAL | 1080 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5b684ceb-a377-47e0-99f7-aec8e0109106 | b5265dc4-ec50-4257-a2df-2e7dd54c58c8 | 2020-12-10 | Warnings | 5b684ceb-a377-47e0-99f7-aec8e0109106 b5265dc4-ec50-4257-a2df-2e7dd54c58c8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.