Aurophen pain away plus sleep aid liquid
Active ingredients (in each15 mL)
Acetaminophen USP 500 mg
Diphenhydramine HCl USP 25 mg
Nighttime Sleep Aid
Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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
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
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.
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.
- do not take more than directed (see overdose warning)
- use only enclosed dosing cupdesigned for use with this product. Do not use any other dosing device.
- mL= milliliter
|adults and children 12 years and over
|children under 12 years
||do not use
- each 15 mL contains: sodium 9 mg
- store between 20-25C (68-77F). Do not refrigerate.
- don't use if shrink band is missing or broken
- see back label for lot number and expiration date
anhydrous citric acid, FD&C Blue no.1, FD&C Red no.40, 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?
2572 Brunswick Pike,
Lawrenceville, NJ 08648
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
Ingredients and appearance - Product information
Aurophen pain away plus sleep aid liquid- Acetaminophen, diphenhydramine hydrochloride
|Product Type||Human OTC Drug Label||Item Code (Source)||NDC: 58602-217|
|Route of Administration||Oral|
|Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D )||500 mgin 15 mL|
|Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M )||25 mgin 15 mL|
|Anhydrous citric acid||( UNII: XF417D3PSL)|
|Fd&c blue no. 1||( UNII: H3R47K3TBD)|
|Fd&c red no. 40||( UNII: WZB9127XOA)|
|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)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC MONOGRAPH NOT FINAL||part343||USA|
Labeler - Aurohealth LLC( 078728447)
|Aurohealth LLC||078728447||MANUFACTURE( 58602-217)|
Package label-principal display panel8 fl oz (237 ml)
See Warnings Information
Pain Away + Sleep aid
Acetaminophen, Diphenhydramine HCl
Pain Reliever, Nighttime Sleep Aid
8 FL OZ
Do not use if printed shrinkband is missing or broken.