Minimum Age Recommendations for Common Cough and Cold Products

In today’s market, the sheer number of cough and cold products available for purchase make it arduous to know how to differentiate between options in the cough and cold section of a pharmacy.

However, between all of the products available, they tend to have similar active ingredients. These products may simply vary by dose or by different active ingredient combinations. One trick to knowing which product to select relates to knowing which active ingredients are contained in each product. 

Like most other medicines, there are minimum recommended ages to abide by while selecting a cough and cold product. While selecting a cough and cold product for an individual less than 18 years of age, it’s important to keep in mind the recommended ages for use. If a product is used in an individual that is below the recommended product age recommendation, harm could be had to the impacted individual.  

FAST FACT: According to an announcement by the United States Food and Drug Administration posted in February 2018, it is recommended that children under 2 years of age should not be given any kind of cough and cold product that contains a decongestant or antihistamine because serious and possibly life-threatening side effects could occur. However, cough and cold products have various minimum age recommendations provided by safety and efficacy studies and those ages are described in this article.

The table below, Table 1, summarizes minimum age recommendations for various cough and cold products according to package inserts and various primary literature sources. Most cold medicines contain antihistamines, cough expectorants, cough suppressants, nasal decongestants, and/or pain relievers.

Cough and cold products are commonly available in combination with multiple active ingredients. If there is a single active ingredient in a combination product that conflicts with a child’s age, that product should be avoided.

Table 1 is not an all-encompassing list of cough and cold products. Rather, it describes age recommendations for commonly-used active ingredients contained in cough and cold products. Note also that the ages listed below may be applicable to only a certain dosage form, so be sure to ask your local pharmacist about which dosage form may be right for your child if you aren’t sure.

Table 1. Minimum Ages for Common Cough and Cold Products

Generic NameBrand Name(s)Minimum Age
First Generation Antihistamines
BrompheniramineN/A6 years
ChlorpheniramineN/A6 years
DiphenhydramineBenadryl6 years
DoxylamineUnisom12 years
Second Generation (Non-Drowsy) Antihistamines
CetirizineZyrtec6 months
FexofenadineAllegra2 years
LoratadineClaritin2 years
Cough Expectorants
Guaifenesin Mucinex4 years
Cough Suppressants
Camphor & mentholVicks Vaporub2 years
CodeineN/A18 years
DextromethorphanDelsym; Robitussin4 years
Nasal Decongestants
Phenylephrine Sudafed PE4 years
PseudoephedrineSudafed12 years
Nasal salineN/A0 months
Pain Relievers
AcetaminophenMapap; Tylenol3 months
IbuprofenAdvil; Motrin6 months
NaproxenAleve; Naprosyn12 years

Disclaimer: Table 1 contains general recommendations. A singular, widely-accepted guideline for minimum recommended ages for cough and cold products does not exist. The ages specified in this article are supported by safety and efficacy data from primary literature sources, package insert specifications, and the advice of tertiary pediatric experts. Always listen to the advice of your child’s pediatrician when selecting a specific cough and cold product.

References:

  1. Gentile DA, Friday GA, Skoner DP. Management of Allergic Rhinitis: Antihistamines and Decongestants. Immunol Allergy Clin NA, 2000, 20(2):355-68.
  2. Walsh, GA. Chapter 15 – Antihistamines (H1 receptor antagonists). Side Effects of Drugs Annual. 2009; 31(297-303).  https://doi.org/10.1016/S0378-6080(09)03115-8 
  3. McMahan Wicker A, Labruzzo BA. Recommendations for the Use of OTC Cough and Cold Medications in Children. US Pharmacist. https://www.uspharmacist.com/article/recommendations-for-the-use-of-otc-cough-and-cold-medications-in-children 
  4. Benadryl (diphenhydramine) [package insert]. Johnson & Johnson Consumer, Inc. McNeil Consumer Healthcare Division. 
  5. Unisom (doxylamine) [prescribing information]. Chattem, Inc. Chattanooga, TN.
  6. Zyrtec (cetirizine) [package insert]. Pfizer, Inc. New York, NY 10017. 
  7. Allegra (fexofenadine) [package insert]. Aventis Pharmaceuticals, Inc. Kansas City, MO 64137.
  8. Claritin (loratadine) [package insert]. Schering Corporation. Kenilworth, NJ 07033. 
  9. Guaifenesin [package insert]. Pharmaceutical Associates, Inc. Greenville, SC 29605. 
  10. Codeine sulfate [package insert]. RLI, 2013. 
  11. Delsym (dextromethorphan) [package insert]. Reckitt Benckiser LLC. Parsippany, NJ 07054.
  12. Sudogest (phenylephrine) [package insert]. Major Pharmaceuticals. Livonia, MI 48150. 
  13. Sudafed (pseudoephedrine) [package insert]. McNeil Consumer Healthcare Division. 
  14. Acetaminophen Dosage Table for Fever and Pain. American Academy of Pediatrics. https://www.healthychildren.org/English/safety-prevention/at-home/medication-safety/Pages/Acetaminophen-for-Fever-and-Pain.aspx 
  15. Mapap Children’s (acetaminophen) [package insert]. Major Pharmaceuticals. Livonia, MI 48150.
  16. Camphotex (camphor/menthol) [package insert]. PureTek Corporation. San Fernando, CA 91340. 
  17. Advil (ibuprofen) [package insert]. Pfizer Inc., Madison, NJ 07940. 
  18. Ibuprofen (Motrin, Advil) Dose Table. St. Louis Children’s Hospital. https://www.stlouischildrens.org/health-resources/dosage-tables/ibuprofen-motrin-advil-dosage-table 
  19. Aleve (naproxen) [package insert]. Bayer. Whippany, NJ 07981. 
  20. Wells TG, Mortensen ME, Dietrich A, et al. Comparison of the Pharmacokinetics of Naproxen Tablets and Suspension in Children. J Clin Pharmacol, 1994, 34(1):30-3.