Label: CHILDRENS COUGH AND COLD CF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 76281-325-24
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 16, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use if you are now taking aprescription
monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or
Parkinson's diseases) 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
• heart disease
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with
smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are taking
any other oral nasal decongestant or stimulant
When using this product
• do not use more than directed
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are
accompanied by fever
• cough lasts more than 7 days, comes back, or is
accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
If pregnant or breast feeding, ask aheaith professional
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• mL = milliliter
age dose children under 4 years do not use children 4 to under
5 mL every 4 hours children 6 to under
10 mL every 4 hours adults and children
12 years and over
20 mL every 4 hours
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
Compare to the active
ingredients in Children's
& Cold CF*
& Cold CF
4 FL OZ (118 mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.COM 1-800-SHOP-CVS BX-128 Rev01
*This product is not manufactured or distributed by
Pfizer, distributor of Children's Robitussin® Cough
& Cold CF.
INGREDIENTS AND APPEARANCE
CHILDRENS COUGH AND COLD CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-325 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color purple Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-325-24 1 in 1 CARTON 06/08/2021 1 118 mL in 1 BOTTLE; 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 06/08/2021 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-325)