Answers to Frequently Asked Questions: 

Is it safe to use the products?  
 
This recall is not being undertaken on the basis of adverse medical events. While the potential for serious medical events is remote, parents and caregivers who purchased these recalled products should discontinue use. If you are not sure about alternative pediatric health treatment options, you should talk to your child’s healthcare provider. Remember, you should never give drug products to infants and children that are not intended for those age groups as this could result in serious harm. Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch 

Have there been any reports of adverse events associated with this product recall?  
 
This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, you should discontinue use of these products. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .

What should I do if I have given this product to my child or infant?  
 
This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch 

What should I do if I have the product in my home?

This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. For information on disposing of over-the-counter medications, please go to www.smarxtdisposal.net. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch 

How to Dispose of Unused Medicines?

Unless instructed otherwise, do not dispose of unused medicines by emptying them into your sink, toilet, or storm drain.

Some states may have regulations regarding pharmacy or community take-back programs in which they may receive and dispose of returned unused drugs for patients. It is recommended that a local pharmacy or local authority be contacted to determine if it participates in such programs.

In the event that medicines cannot be disposed by take-back programs, place them in the household trash taking the following steps.

• Make sure that they are in an unrecognizable sealed container; ensuring that children, pets, and others do not have access to the contents of the container;
• Dispose of the container in household trash.

How do I find NDC number, lot number and expiration date? 
 
Product NDC numbers can be located on the label of the bottle above the brand name. Lot Numbers and Expiration Dates can be found on back /side label of the bottle.

Should I return recalled product to retail stores for a refund? 
 
No. You do not need to return recalled product(s) to retail stores. You can receive acoupon(s) for a free replacement (s) when the product becomes available again. To process your free product coupon you will need the NDC number and Lot number from the product that has been recalled and call Blacksmith Brands at 888 474 3099. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label. 
 
Will you be offering a refund for the product I purchased and has been recalled?  
 
Blacksmith Brands is offering consumers who have purchased products affected by this recall a coupon for a free replacement when the product becomes available again. To process your coupon request you will need the NDC number and Lot number from the product that has been recalled and then call Blacksmith Brands at 888-474-3099. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.