DAYTIME AND NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Chain Drug Consortium, 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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Daytime and Nighttime Cold and Flu Relief
Active ingredients for DAYTIME (in each capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients for NIGHTTIME (in each capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Uses (DAYTIME ONLY)
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Uses (NIGHTTIME ONLY)
- temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Warnings (DAYTIME ONLY)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & children even if you do not notice any signs or symptoms.
Warnings (NIGHTTIME ONLY)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcohol drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 sleep
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 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
-
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.
Keep out of reach of children.
Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & children even if you do not notice any signs or symptoms.
Directions (DAYTIME ONLY)
-
take only as directed – see Overdose warning
-
do not exceed 4 doses per 24 hours
| adults & children 12 yrs & over | 2 capsules with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Directions (NIGHTTIME ONLY)
-
take only as directed
-
do not exceed 4 doses per 24 hours
| adults & children 12 yrs & over | 2 capsules with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
- when using other Daytime or Nighttime products,carefully read each label to ensure correct dosing
Other information (DAYTIME and NIGHTTIME)
-
store at controlled room temperature 15°C to 30°C (59°F to 86°F)
-
avoid excessive heat
Inactive ingredients (DAYTIME ONLY)
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerine, polyethylene glycol 400, povidone K12, propylene glycol, purified water, sorbitol sorbitan solution, white ink.
Inactive ingredients (NIGHTTIME ONLY)
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerine, polyethylene glycol 400, povidone K12, propylene glycol, purified water, sorbitol sorbitan solution, white ink.
| DAYTIME AND NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit |
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| Labeler - Chain Drug Consortium, LLC (101668460) |