Nighttime Cold And Flu Max Softgels
787bff76-0ee2-4e7e-b908-876e4a3e3bfc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Section 50566-9
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
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Section 50567-7
When using this product
• do not use more than directed n excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness
Section 50568-5
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if you have
• liver disease •glaucoma •cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema •trouble urinating due to enlarged prostate gland
Section 50570-1
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.
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
uses
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache• minor aches & pains• fever• runny nose & sneezing
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
• 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.
Directions
•
take only as directed • do not exceed 8 softgels per 24 hrs
• adults & children 12 yrs & over 2 Softgels with water every 6 hrs
• children 4 to under 12 yrs ask a doctor
• children under 4 yrs do not use
Other Information
• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol,
povidone, purified water, silver sheen, sorbitol solution
Questions Or Comments?
1-800-373-6981 (toll-free)
Principal Display Panel
Nighttime
Cold & Flu Max
Softgels
Carton
Active Ingredient (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl - 5 mg
Structured Label Content
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
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
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Section 50567-7 (50567-7)
When using this product
• do not use more than directed n excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if you have
• liver disease •glaucoma •cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema •trouble urinating due to enlarged prostate gland
Section 50570-1 (50570-1)
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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
uses (Uses)
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache• minor aches & pains• fever• runny nose & sneezing
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
• 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.
Directions
•
take only as directed • do not exceed 8 softgels per 24 hrs
• adults & children 12 yrs & over 2 Softgels with water every 6 hrs
• children 4 to under 12 yrs ask a doctor
• children under 4 yrs do not use
Other Information (Other information)
• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.
Inactive Ingredients (Inactive ingredients)
FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol,
povidone, purified water, silver sheen, sorbitol solution
Questions Or Comments? (Questions or comments?)
1-800-373-6981 (toll-free)
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Nighttime
Cold & Flu Max
Softgels
Carton
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl - 5 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:05.391166 · Updated: 2026-03-14T23:13:21.652895