DAYTIME PE NITETIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Publix Super Markets Inc
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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Active ingredients for NIGHTTIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Active ingredients for DAYTIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose (NIGHTTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Purpose (DAYTIME ONLY)
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion (DAYTIME ONLY)
- •
- cough due to minor throat and bronchial irritation
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- sore throat
- •
- headache
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- minor aches and pains
- •
- fever
- •
- relieves runny nose and sneezing (NIGHTTIME ONLY)
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- •
- more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using these products
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.
- •
- to make a child sleepy
Ask a doctor before use if you have
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- heart disease (DAYTIME ONLY)
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- thyroid disease (DAYTIME ONLY)
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- diabetes (DAYTIME ONLY)
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- high blood pressure (DAYTIME ONLY)
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- cough that occurs with too much phlegm (mucus)
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- liver disease
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- persistent or chronic cough as occurs with smoking, asthma or emphysema
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- trouble urinating due to an enlarged prostate gland
- •
- glaucoma (NIGHTTIME ONLY)
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- a breathing problem such as emphysema or chronic bronchitis (NIGHTTIME ONLY)
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using these products
- •
- do not use more than directed
In addition, when using NIGHTTIME:
- •
- 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 (DAYTIME ONLY)
- •
- redness or swelling is present
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- •
- 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.
Keep out of reach of children.
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 recommended - see Liver warning
- •
- take Nighttime OR Daytime
NIGHTTIME SOFTGELS
- •
- do not exceed 4 doses per 24 hours
adults and children 12 years and over
|
2 softgels with water every
6 hours
|
children 4 to under 12 years
|
ask a doctor
|
children under 4 years
|
do not use
|
DAYTIME SOFTGELS
- •
- do not exceed 6 doses per 24 hours
adults and children 12 years and over
|
2 softgels with water every
4 hours
|
children 4 to under 12 years
|
ask a doctor
|
children under 4 years
|
do not use
|
- •
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other information
- •
- store at 20°-25°C (68°-77°F)
Inactive ingredients
NIGHTTIME D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
DAYTIME edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Principal Display Panel
See New Warnings Information
NON-DROWSY
daytime PE
ACETAMINOPHEN - ACHES, FEVER
DEXTROMETHORPHAN HBr - COUGH
PHENYLEPHRINE HCl - NASAL CONGESTION
PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT
MULTI-SYMPTOM
COLD/FLU RELIEF
Compare to Active Ingredients in Vicks® DayQuil®
ACTUAL SIZE
nitetime
ACETAMINOPHEN - ACHES, FEVER
DEXTROMETHORPHAN HBr - COUGH
DOXYLAMINE SUCCINATE - SNEEZING, RUNNY NOSE
PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE
MULTI-SYMPTOM
COLD/FLU RELIEF
Compare to Active Ingredients in Vicks® NyQuil®
ACTUAL SIZE
Daytime PE Nitetime Carton Image 2