Cold Preparation by New Genesis/Monticello Drug LLC Drug Facts
Cold Preparation by
Drug Labeling and Warnings
Cold Preparation by is a Otc medication manufactured, distributed, or labeled by New Genesis/Monticello Drug LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD PREPARATION- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
New Genesis/Monticello Drug LLC
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.
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Drug Facts
Active ingredients (in each 15 mL, 1 tablespoon)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
- more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if the user has
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
When using this product,
- avoid alcoholic drinks
- do not use more than directed (see overdose warning)
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- cough comes back or occurs, with 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) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as recommended (see overdose warning)
- do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
- use dosage cup provided
- tbsp=tablespoon, mL=milliliter
| adults and children 12 years and over | 2 tablespoons (30 mL) every 4 hours |
| children 6 to 11 years | 1 tablespoon (15 mL) every 4 hours |
| children 4 to 5 years | do not use unless directed by a doctor |
| children under 4 years | do not use |
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
Inactive ingredients
citric acid, FD&C yellow 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose
Principal Display Panel
*Compare to active ingredients in Vicks® DayQuil®
Cold Preparation
- Acetaminophen Pain reliever/fever reducer
- Dextromethorphan HBr cough suppressant
- Phenylephrine HCl Nasal decongestant
For cough and sinus relief
For ages 6 and over
FL OZ (mL)
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®
Failure to follow these warnings could result in serious consequences.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
Distributed by:
Monticello Drug Company, Jacksonville, FL 32254
| COLD PREPARATION
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid |
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| Labeler - New Genesis/Monticello Drug LLC (079396165) |