CHILDRENS PLUS COUGH AND RUNNY NOSE- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
Childrens Plus Cough and Runny Nose by
Drug Labeling and Warnings
Childrens Plus Cough and Runny Nose by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each 5 mL)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount
- with other drugs contaning acetaminophen
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
- to make a child sleepy
- in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if the child has
- liver disease
- glaucoma
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Ask a doctor or pharmacist before use if the child is taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not exceed recommended dose (see overdose warning )
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain or cough gets worse or lasts for more than 5 days
- 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use.
- mL = milliliter
- shake well before using
- do not give more than 5 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- if needed, repeat dose every 4 hours while symptoms last
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use - Other Information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
*Compare To Active Ingredients in Children's Tylenol® Plus Cough & Runny Nose
Children's Plus COUGH & RUNNY NOSE
Pain Reliever, Fever Reducer,
Cough Suppressant, Antihistamine
RELIEVES:
- Fever & Sore Throat
Acetaminophen
- Sneezing & Runny Nose
Chlorpheniramine Maleate
- Cough
Dextromethorphan HBr
Alcohol 0.005%
Oral Suspension
FOR AGES 6 TO 11 YEARS
FL OZ (mL)
CHERRY
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS,TN 38118
www.fredsinc.com
Questions or comments: 1855-331-FRED (3733)
- Package Label
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INGREDIENTS AND APPEARANCE
CHILDRENS PLUS COUGH AND RUNNY NOSE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55315-297 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55315-297-04 1 in 1 BOX 12/17/2015 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/17/2015 Labeler - Freds Inc (005866116)
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