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- NDC Code(s): 12546-110-00, 12546-110-01, 12546-110-02, 12546-110-03, view more
12546-110-04, 12546-110-14, 12546-110-16, 12546-110-18, 12546-110-24, 12546-110-30, 12546-110-40, 12546-110-80, 12546-110-96, 12546-110-99
- Packager: Mondelez Global LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 21, 2024
If you are a consumer or patient please visit this version.
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- Active ingredient
- Purposes
<Cough suppressant, Oral Anesthetic>
- Uses
<temporarily relieves:>
- cough due to a cold
- occasional minor irritation or sore throat
- Warnings
<Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.>
- Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- sore mouth does not improve in 7 days
- irritation, pain, or redness persists or worsens
- Keep out of reach of children
Enter section text here
- Directions
- adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
- children under 5 years: ask a doctor
- Other information
- 10 calories per drop
- Contains: SOY.
- Inactive ingredients
<beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>
- Questions
<Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website atwww.gethalls.com>
- OTC Principal Display Panel
- INGREDIENTS AND APPEARANCE
HALLSHONEY LEMON
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.5mg Inactive Ingredients Ingredient Name Strength HONEY (UNII: Y9H1V576FH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) EUCALYPTUS OIL (UNII: 2R04ONI662) .BETA.-CAROTENE (UNII: 01YAE03M7J) Product Characteristics Color yellow (yellow) Score no score Shape OVAL Size 21mm Flavor HONEY (HONEY LEMON) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-110-18 18 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 09/16/2022 2 NDC:12546-110-30 30 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 3 NDC:12546-110-24 24 in 1 BAG; Type 0: Not a Combination Product 12/02/2019 06/11/2023 4 NDC:12546-110-40 40 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 07/22/2023 5 NDC:12546-110-80 80 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 6 NDC:12546-110-16 16 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 09/16/2022 7 NDC:12546-110-96 96 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 04/21/2020 8 NDC:12546-110-14 14 in 1 PACKAGE; Type 0: Not a Combination Product 03/24/2019 9 NDC:12546-110-99 160 in 1 BAG; Type 0: Not a Combination Product 03/24/2019 06/21/2024 10 NDC:12546-110-02 150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 09/16/2022 11 NDC:12546-110-03 2400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 09/16/2022 12 NDC:12546-110-04 720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 12/02/2019 09/16/2022 13 NDC:12546-110-00 250 in 1 JAR; Type 0: Not a Combination Product 07/06/2022 14 NDC:12546-110-01 140 in 1 BAG; Type 0: Not a Combination Product 04/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/24/2019 Labeler -Mondelez Global LLC(091849786)
Establishment Name Address ID/FEI Business Operations Mondelez Canada Inc. 246791201 manufacture(12546-110)
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More Info on this Drug
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HALLS HONEY LEMON- menthol lozenge
Number of versions: 17
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jun 24, 2024 | 18 (current) | download |
| Jul 21, 2023 | 17 | download |
| Oct 5, 2022 | 16 | download |
| Aug 29, 2022 | 15 | download |
| Jun 24, 2022 | 14 | download |
| Jun 21, 2021 | 13 | download |
| Nov 26, 2019 | 12 | download |
| Nov 6, 2019 | 11 | download |
| Oct 22, 2019 | 10 | download |
| Mar 25, 2019 | 9 | download |
| Jun 15, 2017 | 8 | download |
| Jan 23, 2017 | 7 | download |
| Nov 4, 2016 | 6 | download |
| Mar 25, 2016 | 5 | download |
| Dec 12, 2013 | 3 | download |
| Oct 18, 2013 | 2 | download |
| Apr 2, 2012 | 1 | download |
RxNorm
HALLS HONEY LEMON- menthol lozenge
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1250189 | menthol 7.5 MG Oral Lozenge | PSN |
| 2 | 1250189 | menthol 7.5 MG Oral Lozenge | SCD |
| 3 | 1250191 | Halls 7.5 MG Oral Lozenge | PSN |
| 4 | 1250191 | menthol 7.5 MG Oral Lozenge [Halls] | SBD |
| 5 | 1250191 | Halls 7.5 MG Oral Lozenge | SY |
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HALLS HONEY LEMON- menthol lozenge
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NDC Codes
HALLS HONEY LEMON- menthol lozenge
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 12546-110-00 |
| 2 | 12546-110-01 |
| 3 | 12546-110-02 |
| 4 | 12546-110-03 |
| 5 | 12546-110-04 |
| 6 | 12546-110-14 |
| 7 | 12546-110-16 |
| 8 | 12546-110-18 |
| 9 | 12546-110-24 |
| 10 | 12546-110-30 |
| 11 | 12546-110-40 |
| 12 | 12546-110-80 |
| 13 | 12546-110-96 |
| 14 | 12546-110-99 |
