Overnight Cold and Flu — v3

Overnight Cold and Flu

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Version

v3

Effective date

September 29, 2025

Original packager

Yes

Sections captured

20

Identifiers

Document ID
3fedd891-4570-9f01-e063-6294a90af835
Set ID
eef00453-9f4f-4a05-bb4e-49b94705b52c
Application numbers
M012
Product NDCs
68163-698
Package NDCs
68163-698-06
Original packager NDCs

Names & Manufacturers

Brand names
Overnight Cold and Flu
Generic names
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL
Manufacturer names
RARITAN PHARMACEUTICALS
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
362O9ITL9D, 9D2RTI9KYH, YAN7R5L890
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

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
Active Ingredient Table (1)

Sequence 1

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Triprolidine HCl 2.5 mgAntihistamine
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Package Label Principal Display Panel (1)

Sequence 1

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
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

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
Purpose Table (1)

Sequence 1

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Triprolidine HCl 2.5 mgAntihistamine
Questions (1)

Sequence 1

Questions or comments? 1-866-467-2748
Spl Product Data Elements (1)

Sequence 1

Overnight Cold and Flu Acetaminophen, Dextromethorphan HBr, Triprolidine HCl ANHYDROUS CITRIC ACID ASCORBIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate
Warnings (1)

Sequence 1

Warnings 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. If pregnant or breast-feeding, ask a health professional before use. 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.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Overnight Cold and Flu'],
 'generic_name': ['ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['RARITAN PHARMACEUTICALS'],
 'package_ndc': ['68163-698-06'],
 'product_ndc': ['68163-698'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3fedd891-4570-9f01-e063-6294a90af835'],
 'spl_set_id': ['eef00453-9f4f-4a05-bb4e-49b94705b52c'],
 'substance_name': ['ACETAMINOPHEN',
                    'DEXTROMETHORPHAN HYDROBROMIDE',
                    'TRIPROLIDINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', '9D2RTI9KYH', 'YAN7R5L890']}