Severe Cold and Cough Relief by Hy-Vee Drug Facts
Severe Cold and Cough Relief by
Drug Labeling and Warnings
Severe Cold and Cough Relief by is a Otc medication manufactured, distributed, or labeled by Hy-Vee. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SEVERE COLD AND COUGH RELIEF DAYTIME- acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid
Hy-Vee
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 Facts
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Uses
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- nasal congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
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 inclide:
- skin reddening
- blisters
- rash
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.
Do not use
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 4 hours
- chlldren under 12 years of age: do not use
Other information
- each 30 mL contains: sodium 16 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltito, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
*COMPARE TO the Active Ingredients of Theraflu® Daytime Severe Cold & Cough
Severe Cold & Cough Relief
Acetaminophen 650 mg - Pain reliever/Fever reducer
Dextromethorphan HBr 20 mg - Cough Suppressant
Phenylephrine HCl 10 mg - Nasal Decongestant
Daytime
Relieves:
Nasal Congestion Body Ache
Sore Throat Cough
Fever Headache
Ages 12 +
10 % Alcohol
Cherry Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & cough.
DISTRIBUTED BY HY-VEE, INC.
5820 WESTOWN PARKWAY
WEST DES MOINES, IA 50266
| SEVERE COLD AND COUGH RELIEF
DAYTIME
acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Labeler - Hy-Vee (006925671) |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.