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Drug Facts
Overnight Cold And Flu Solution
FDA Label NDC 68163-698
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals for the product Overnight Cold And Flu (NDC 68163-698). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 20 mL) | Purposes |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg | Cough suppressant |
Triprolidine HCl 2.5 mg | Antihistamine |
Uses
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ minor aches and pains▪ sore throat▪ headache▪ runny nose▪ sneezing▪ itching of the nose or throat▪ itchy, watery eyes due to hay fever
▪ temporarily reduces fever▪ controls cough to help you get to sleep
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take:
▪ more than 4000 mg in 24 hours, which is the maximum daily amount▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks daily while using this product
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
▪ 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
▪ 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.
Ask A Doctor Before Use If You Have
▪ liver disease▪ glaucoma▪ trouble urinating due to an enlarged prostate gland▪ a breathing problem such as emphysema or chronic bronchitis▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema▪ cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking the blood thinning drug warfarin▪ taking sedatives or tranquilizers
When Using This Product
▪ do not use more than directed▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ avoid alcoholic drinks▪ use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
▪ pain or cough 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 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 4 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours▪ children under 12 years of age: do not use
Other Information
▪ each 20 mL contains: sodium 10 mg▪ low sodium▪ store at room temperature▪ do not refrigerate
Inactive Ingredients
anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 180 Ml Bottle Label
Compare to the active ingredients in Mucinex® Nightshift Cold & Flu*
NDC 68163-698-06
Overnight Cold & Flu
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine
Relieves:
- Cough
- Fever
- Sore throat
- Runny nose
- Sneezing
Nighttime relief for
a Better Morning
6 FL OZ (180 mL)For Ages 12+
Tamper evident: do not use if printed seal under cap is broken or missing
Maximum Strength per 4-hour dose
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu.
Drx Choice Overnight Cold And Flu Relief (Mucinex 01)
* Please review the disclaimer below.
