NDC | 37000-759-06 |
Set ID | 87346412-e8d4-6502-e053-2a91aa0a8331 |
Category | HUMAN OTC DRUG LABEL |
Packager | Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 15 mL)
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks daily 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 is 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- peristent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 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.
- SPL UNCLASSIFIED SECTION
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label
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INGREDIENTS AND APPEARANCE
VICKS CHILDRENS FCOLD MULTI SYMPTOM
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-759 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) SODIUM CHLORIDE (UNII: 451W47IQ8X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BETA CAROTENE (UNII: 01YAE03M7J) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color orange Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-759-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/23/2019 Labeler - Procter & Gamble Manufacturing Company (004238200)