Label: OVERNIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, triprolidine hcl solution
- NDC Code(s): 68163-698-06
- Packager: RARITAN PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated May 9, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 4000 mg in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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
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- liver disease
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- do not use more than directed
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- avoid alcoholic drinks
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- use caution when driving a motor vehicle or operating machinery
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Directions
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- do not take more than directed (see Overdose warning)
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- do not take more than 4 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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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 – AntihistamineRelieves:
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- Cough
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- Fever
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- Sore throat
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- Runny nose
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- Sneezing
Nighttime relief for
a Better Morning6 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.
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INGREDIENTS AND APPEARANCE
OVERNIGHT COLD AND FLU
acetaminophen, dextromethorphan hbr, triprolidine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-698 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASCORBIC ACID (UNII: PQ6CK8PD0R) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-698-06 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/21/2023 Labeler - RARITAN PHARMACEUTICALS (127602287)