Amerisouce Bergen Severe Day Time Drug Facts
Amerisouce Bergen Severe Day Time Drug Facts
Drug Labeling and Warnings
Drug Details
GOOD NEIGHBOR PHARMACY SEVERE DAY TIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Amerisource Bergen
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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Amerisouce Bergen Severe Day Time Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 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
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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
- high blood pressure
- thyroid disease
- diabetes
- 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
- fever gets worse or lasts more than 3 days
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- you get nervous, dizzy or sleepless
- 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 4 doses 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 blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Package/Label Principal Display Panel
Compare to Vicks® DayQuil® Severe Cold & Flu Caplets active ingredients
See New Warnings
MAXIMUM STRENGTH
Severe Day Time
pain reliever, fever reducer, cough suppressant, nasal decongestant, expectorant
Cold & Flu
Acetaminophen – Aches, Fever & Sore Throat
Dextromethorphan HBr – Cough
Guaifenesin – Chest Congestion
Phenylephrine HCl – Nasal Congestion
Non-Drowsy
Alcohol Free/Antihistamine Free
24 Caplets
actual size
| GOOD NEIGHBOR PHARMACY SEVERE DAY TIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated |
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| Labeler - Amerisource Bergen (007914906) |