DAYTIME SEVERE COLD AND COUGH by Fred's, Inc.
Medically reviewed on February 16, 2017
Dosage form: syrup
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: Fred's, Inc.
NDC Code: 55315-006
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
Dextromethorphan HBr, USP 20 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
- 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.
- 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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- taking the blood thinning drug warfarin
- do not exceed recommended dosage
- 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: sodium 17 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
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*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Daytime Severe Cold & Cough.
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TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.
4300 NEW GETWELL RD
MEMPHIS, TN 38118
Maximum Strength Per 4 Hour Dose.
Each dose (per 30 mL) of Syrup contains:
650 mg - ACETAMINOPHEN, USP
(Pain Reliever/Fever Reducer)
20 mg - DEXTROMETHORPHAN HBr, USP
10 mg - PHENYLEPHRINE HCl, USP
- Nasal Congestion
- Sore Throat Pain
- Body Ache
8.3 FL OZ (245.5 mL)
Alcohol Content: 10%
Compare to the active ingredients in
Daytime Severe Cold & Cough*
|DAYTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr and phenylephrine hcl syrup
|Labeler - Fred's, Inc. (005866116)|
|Registrant - Aurohealth LLC (078728447)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.