Night Time Severe Cold and Cough
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
(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)|