Overview\nJapan’s Ministry of Health, Labour and Welfare (MHLW) has issued “The Standards for Marketing Approval of Cold Remedies” for OTC products, and PMDA provides an English reference version. The cold remedy standards referenced in the PMDA compilation were issued March 25, 2015 (Notification PB No.28). \n\nThese standards are used in practice to:\n- Define acceptable dosage forms and basic dosing rules\n- Set age-related limitations (including when pediatric dosing is not allowed)\n- Constrain what indications (claims) can be used, and when certain symptom-claims require certain active-ingredient types\n- Limit packaging units for syrups\n\n# Key requirements to design an approvable OTC cold remedy\n\n## 1) Dosage forms (what forms are covered)\nCold remedies covered in the standard use the following dosage forms:\n- Tablets, capsules, pills, granules, powders, and syrups \n\n## 2) Dosage and administration (how products should be taken)\nGeneral administration framework:\n- Non-syrup cold remedies: oral administration 3 times daily within 30 minutes after a meal\n- Syrups: in principle after every meal; may also be taken before bedtime if needed\n- If absolutely necessary: may be taken about every 4 hours, up to 6 times/day \n\n### Pediatric eligibility restrictions (examples that frequently affect labeling)\nThe standard includes explicit “not approved” age cutoffs tied to dosage form and certain ingredient groupings, for example:\n- Certain solid forms are not approved below specific ages (e.g., children under 5 for some capsule/tablet/pill scenarios; under 3 for others) \n- If the formula contains specified ingredients (e.g., certain analgesic/antihistamine/other ingredient groupings described in the standard), dosage for children under 15 years is not approved \n- For formulas containing specified ingredient groups, additional pediatric cutoffs apply (e.g., “under 8 years not approved” for some groups; “under 5 years not approved” for others) \n\n### Age coefficients (how child doses are scaled)\nFor children, maximum daily doses are set by multiplying adult limits by age coefficients in Table 3, including:\n- 15 years and over: 1\n- 11 to under 15: 2/3\n- 7 to under 11: 1/2\n- 3 to under 7: 1/3\n- 1 to under 3: 1/4\n- 6 months to under 1 year: 1/5 \n\n## 3) Indications (what claims you can make)\n### Baseline “common cold” symptom relief scope\nThe standard allows claims within a “common cold symptom relief” scope, including:\n- Runny/stuffy nose, sneezing, sore throat, cough, phlegm (sputum)\n- Chills (feeling cold due to fever), fever, headache, joint pain, muscle pain \n\n### Symptom-claim dependency on active-ingredient types\nA key labeling constraint is that some symptom claims cannot be used unless relevant types of active ingredients are included. For example:\n- Claims for runny nose / stuffy nose / sneezing require including ingredients from a specified “Column” (as defined in Table 1)\n- Claims for cough require including ingredients from specified columns\n- Claims for phlegm (sputum) require specific listed actives or actives from specified columns \n\nPractical takeaway: when planning your Product Information/label, verify that every symptom claim has a corresponding qualifying active ingredient category.\n\n## 4) Packaging units (syrup-specific constraint)\nFor syrups, the standard limits maximum container volume to a 2-day supply at the maximum daily dosage for children aged 6 years. \n\n## 5) Formulation constraints (why “cold combo” design is not arbitrary)\nThe standard uses a column/group structure (Table 1) to manage combination products. While the detailed matrix is extensive, the practical impact is:\n- Upper limits are set (generally by maximum daily dose per active ingredient) \n- Combination rules can require that normalized sums of doses stay under specific thresholds in certain scenarios (e.g., when combining multiple actives) \n- Some combinations are explicitly not acceptable (e.g., certain pairs or combinations involving specified categories) \n\n# Practical checklist for regulatory planning\n- Confirm your product’s dosage form is within the allowed set. \n- Build dosing that matches the administration schedule and respects pediatric eligibility cutoffs. \n- Align each intended symptom claim with qualifying ingredient categories so claims are supportable. \n- If using a syrup, confirm packaging size does not exceed the stated 2-day supply limit. \n\n# Reference (PDF)\n- PMDA – English version of the Standards for Marketing Approval of Cold Remedies, etc. (PDF)\n