Advanced Rx - Puregen - Multi-symptom Nighttime Cold & Flu Relief (80513-302)
fa1b60b1-49cb-1211-e053-6394a90a0a46
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg
Uses
Temporarily relieves common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
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 and for children even if you do not notice any signs or symptoms.
Section 51945-4
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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 products containing acetaminophen (prescription or non-prescription). 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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 an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- 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, and tranquilizers may increase drowsiness
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 rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
- take only as directed
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | take 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Questions?
call toll-free 1-800-630-8895
Other Information
- store at room temperature
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.
Active Ingredient (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Structured Label Content
Uses (USES)
Temporarily relieves common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
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 and for children even if you do not notice any signs or symptoms.
Section 51945-4 (51945-4)
Purpose (PURPOSE)
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Warnings (WARNINGS)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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 products containing acetaminophen (prescription or non-prescription). 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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 an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- 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, and tranquilizers may increase drowsiness
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 rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions (DIRECTIONS)
- take only as directed
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | take 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Questions? (QUESTIONS?)
call toll-free 1-800-630-8895
Other Information (OTHER INFORMATION)
- store at room temperature
Inactive Ingredients (INACTIVE INGREDIENTS)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.
Active Ingredient (in Each Softgel) (ACTIVE INGREDIENT (IN EACH SOFTGEL))
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:35.671590 · Updated: 2026-03-14T23:03:44.598062