Night Time Severe Cold and Cough
Medically reviewed on Feb 14, 2017
Dosage form: syrup
Ingredients: ACETAMINOPHEN 650mg in 30mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: Fred's, Inc.
NDC Code: 55315-004
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.
(in each 30 mL (2 TBSP))
Acetaminophen, USP 650 mg
Diphenhydramine HCl, USP 25 mg
Phenylephrine HCl, USP 10 mg
Pain Reliever/Fever Reducer
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- nasal and sinus congestion
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
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 daily while using this product
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
- in a child under 12 years of age
- if you are allergic to acetaminophen
- 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 the skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help 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.
- do not use more than directed
- measure the dose correctly using the enclosed dosing cup
- take every 4 hours in dosing cup provided, while symptoms persist
- do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
- TBSP = Tablespoon, mL = milliliter
|adults and children 12 years of age and over||30 mL (2 TBSP)
|children under 12 years of age||do not use
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- each 30 mL contains: potassium 9 mg, sodium 15 mg
- Store at 20-25oC (68-77oF)
- TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions or comments?
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Nighttime Severe Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: Fred's, Inc.
4300 NEW GETWELL RD
Maximum Strength Per 4 Hour Dose
Each dose (per 30 mL) of Syrup contains:
650 mg - ACETAMINOPHEN, USP
(Pain Reliever/Fever Reducer)
25 mg - DIPHENHYDRAMINE HCl, USP
10 mg - PHENYLEPHRINE HCl, USP
- Nasal Congestion
- Sore Throat Pain
- Runny Nose
- Body Ache
8.3 FL OZ (245.5 mL)
Alcohol Content: 10%
Compare to the Active Ingredients In
Nighttime Severe Cold&Cough*
|NIGHT TIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup
|Labeler - Fred's, Inc. (005866116)|
|Registrant - Aurohealth LLC (078728447)|