Label: AUROPHEN DAYTIME NIGHTTIME- acetaminophen, diphenhydramine hcl kit
- NDC Code(s): 58602-224-20, 58602-225-20, 58602-226-20
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated December 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts - Day Time
- Drug Facts - Night Time
- Purpose - Day Time
- Purpose - Night Time
- Uses - Day Time
- Uses - Night Time
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Warnings - Day 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.
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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.
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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.
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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
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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?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)
AUROHEALTH
NDC 58602-226-20Compare to the active ingredients in TYLENOL® Extra Strength Adult Rapid Blast Cherry*
AUROPHEN
Pain Reliever
Fever Reducer
Extra
Strength
Adult Acetaminophen oral Liquid 500 mg/15 mL
Rapid Burst
Cherry Flavor
See Warnings Information
Pain Away + Sleep aid
Acetaminophen 500 mg/15 mL-Pain Reliever
Diphenhydramine HCl 25 mg/15 mL-Nighttime Sleep Aid
Berry
(Alcohol free)
DAY AND NIGHT PAIN RELIEF
Total 16 FL OZ (474 mL) - 2 x 8 FL OZ (237 mL)
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INGREDIENTS AND APPEARANCE
AUROPHEN DAYTIME NIGHTTIME
acetaminophen, diphenhydramine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-226 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-226-20 1 in 1 CARTON; Type 0: Not a Combination Product 11/04/2015 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 AUROPHEN DAYTIME
adult extra strength pain reliever/fever reducer liquidProduct Information Item Code (Source) NDC:58602-224 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:58602-224-20 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 11/04/2015 07/01/2022 Part 2 of 2 AUROPHEN NIGHTTIME
aurophen pain away plus sleep aid liquidProduct Information Item Code (Source) NDC:58602-225 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:58602-225-20 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 11/04/2015 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 11/04/2015 07/01/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-226)