695t Heb 37808-191 Daytime Nighttime Cold & Flu Softgels Combo 48 Count
db19b8c7-0334-0664-e053-2a95a90ad61f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Medication Information
Warnings and Precautions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 doses 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Indications and Usage
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
Dosage and Administration
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
adults & children 12yrs & over: 2 softgels with water every 4 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
Description
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Section 44425-7
Other information
• store at room temperature
Section 50565-1
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). 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
• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough get 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 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
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 51727-6
Inactive ingredients
FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Section 51945-4
Section 53413-1
Questions? Call 1-877-290-4008
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Section 55106-9
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Other Information
Other information
- store at room temperature
Structured Label Content
Indications and Usage (34067-9)
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
Dosage and Administration (34068-7)
Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
adults & children 12yrs & over: 2 softgels with water every 4 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
Warnings and Precautions (34071-1)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 doses 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Section 44425-7 (44425-7)
Other information
• store at room temperature
Section 50565-1 (50565-1)
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). 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
• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough get 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 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
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Section 50569-3 (50569-3)
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 51727-6 (51727-6)
Inactive ingredients
FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions? Call 1-877-290-4008
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Section 55106-9 (55106-9)
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Other Information (OTHER INFORMATION)
Other information
- store at room temperature
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:34.309169 · Updated: 2026-03-14T23:07:34.278056