TOPCARE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate
Topco Associates LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Topco Associates LLC. Cold & Flu Drug Facts
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Uses
- •
- temporarily relieves these symptoms due to a cold or flu:
- •
- minor aches and pains
- •
- headache
- •
- cough
- •
- sore throat
- •
- nasal and sinus congestion
- •
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- 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 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- in children under 12 years of age
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- cough that occurs with too much phlegm (mucus)
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- •
- pain, cough, or nasal congestion 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.
- •
- nervousness, dizziness, or sleeplessness occurs
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- •
- do not take more than directed (see Overdose warning)
- •
- adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
- •
- children under 12 years: do not use
Inactive ingredients
edible dye-free ink*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Uses
- •
- temporarily relieves these symptoms due to a cold or flu:
- •
- minor aches and pains
- •
- headache
- •
- nasal and sinus congestion
- •
- cough
- •
- sore throat
- •
- runny nose
- •
- sneezing
- •
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- 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 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- in children under 12 years of age
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 exceed recommended dosage
- •
- may cause marked drowsiness
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Stop use and ask a doctor if
- •
- pain, cough, or nasal congestion 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.
- •
- nervousness, dizziness, or sleeplessness occurs
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- •
- do not take more than directed (see Overdose warning)
- •
- adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
- •
- children under 12 years: do not use
Inactive ingredients
edible dye-free ink*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Package/Label Principal Display Panel
MULTI-SYMPTOM
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
DYE-FREE
Free of Artificial Dyes and Preservatives
actual size
COMPARE TO ALKA-SELTZER PLUS® COLD & FLU DAY active ingredients
10 DAYTIME LIQUID GELS†
MULTI-SYMPTOM
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Doxylamine Succinate
Antihistamine
Phenylephrine HCl
Nasal Decongestant
DYE-FREE
Free of Artificial Dyes and Preservatives
COMPARE TO ALKA-SELTZER PLUS® COLD & FLU NIGHT active ingredients
10 NIGHTTIME LIQUID GELS†
†LIQUID FILLED CAPSULES
| TOPCARE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit |
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| Labeler - Topco Associates LLC (006935977) |