GOOD SENSE SEVERE DAYTIME COLD AND FLU SEVERE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate
L. Perrigo Company
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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Perrigo Severe Day Time Cold & Flu Severe Night Time Cold & Flu Drug Facts
Active ingredients (in each caplet) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- •
- fever
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- headache
- •
- sore throat
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- minor aches and pains
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- promotes nasal and/or sinus drainage
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
Ask a doctor before use if you have
- •
- thyroid disease
- •
- diabetes
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, 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.
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
- •
- take only as directed - see overdose warning
- •
- do not exceed 8 caplets per 24 hrs
|
adults & children 12 yrs & over |
2 caplets with water every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 yrs |
do not use |
Inactive ingredients
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Active ingredients (in each caplet) Nighttime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- cough to help you sleep
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- runny nose and sneezing
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- promotes nasal and/or sinus drainage
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
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- diabetes
- •
- high blood pressure
- •
- thyroid disease
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough such as occurs with smoking, asthma, 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 use more than directed
- •
- 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
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, 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.
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
- •
- take only as directed - see overdose warning
- •
- do not exceed 8 caplets per 24 hrs
|
adults & children 12 yrs & over |
2 caplets with water every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 yrs |
do not use |
Inactive ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Package/Label Principal Display Panel
Maximum Strength Relief
Non-Drowsy
Pain Reliever, Fever Reducer
Nasal Decongestant
Cough Suppressant
Expectorant
Severe DayTime Cold & Flu
Actual Size
Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Cough
Chest Congestion
Acetaminophen
Phenylephrine HCl
Dextromethorphan HBr
Guaifenesin
Compare to active ingredients of Vicks® DayQuil®
Severe+ VapoCOOL™
100% SATISFACTION GUARANTEED
16 Coated Caplets
VaporIce™
Maximum Strength Relief
Pain Reliever, Fever Reducer
Nasal Decongestant
Antihistamine, Cough Suppressant
Severe NightTime Cold & Flu
Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Sneezing, Runny Nose
Cough
Actual Size
Acetaminophen
Phenylepherine HCl
Doxylamine Succinate
Dextromethorphan HBr
Compare to active ingredients of Vicks® NyQuil®
Severe+ VapoCOOL™
100% SATISFACTION GUARANTEED
8 Coated Caplets
VaporIce™
| GOOD SENSE SEVERE DAYTIME COLD AND FLU SEVERE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit |
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| Labeler - L. Perrigo Company (006013346) |