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
Drug Label Information
Updated November 22, 2024
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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 Drug M012 04/21/2023 Labeler - RARITAN PHARMACEUTICALS (127602287)