Core Values 44-012014-New-Deilsted
Cold and Flu by
Drug Labeling and Warnings
Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD AND FLU DAYTIME/NIGHTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate
Harmon Store 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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Core Values 44-012014-New-Deilsted
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- minor aches and pains
- fever
- cough due to minor throat and bronchial irritation
- headache
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- child takes more than 5 doses in 24 hours
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
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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 the user has
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- diabetes
- thyroid disease
- high blood pressure
Stop use and ask a doctor if
- fever gets worse or lasts more than 3 days
- nervousness, dizziness, or sleeplessness occur
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
-
do not take more than directed
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 5 doses per 24 hours
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other information
-
each 15 mL contains: sodium 13 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
Active Ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- runny nose and sneezing
- minor aches and pains
- headache
- cough due to minor throat and bronchial irritation
- fever
- sore throat
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
- if you have ever had an allergic reaction to this product or any of its ingredients
- 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
- difficulty in urination due to enlargement of the prostate gland
- 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
- glaucoma
- liver disease
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
- excitability may occur, especially in children
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Directions
-
do not take more than directed
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 4 doses per 24 hours
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
Other information
-
each 30 mL contains: sodium 18 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive ingredients
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Principal display panel
CORE VALUES™
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu Multi-Symptom Relief & Vicks® NyQuil® Cold & Flu Nighttime Relief†
Daytime
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Non-Drowsy
Alcohol-Free
menthol flavor
Nighttime
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Doxylamine succinate
Antihistamine
Alcohol-Free
eucalyptus Mint flavor
TWO - 12 FL OZ (355 mL) BOTTLES / TOTAL 24 FL OZ (710 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
50844 REV0318A01201402
Distributed by: Liberty Procurement Co. Inc.
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com
†These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark
VICKS® DayQuil® Cold & Flu Multi-Symptom Relief & VICKS® NyQuil® Cold & Flu Nighttime Relief.
Core Values 44-012014
| COLD AND FLU
DAYTIME/NIGHTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit |
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| Labeler - Harmon Store Inc. (804085293) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | manufacture(63940-123) , pack(63940-123) | |
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